Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-000131-51
    Sponsor's Protocol Code Number:1921
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2019-000131-51
    A.3Full title of the trial
    Preoperative endoscopic treatment with fosfomycin and metronidazole in patients with right-sided colon cancer and colon adenoma: a clinical proof-of-concept intervention study
    MEFO trial
    Præoperativ endoskopisk behandling med fosfomycin og metronidazol hos patienter med højresidig coloncancer og colonadenom: et klinisk proof-of-concept interventionsstudie
    MEFO studiet
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preoperative endoscopic treatment with fosfomycin and metronidazole in patients with right-sided colon cancer and colon adenoma: a clinical proof-of-concept intervention study
    MEFO trial
    Præoperativ endoskopisk behandling med fosfomycin og metronidazol hos patienter med højresidig coloncancer og colonadenom: et klinisk proof-of-concept interventionsstudie
    MEFO studiet
    A.3.2Name or abbreviated title of the trial where available
    MEFO trial
    MEFO studiet
    A.4.1Sponsor's protocol code number1921
    A.5.4Other Identifiers
    Name:Research Ethics Committee numberNumber:66694
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorZealand University Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZealand University Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportReponex Farmaceuticals
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZealand University Hospital
    B.5.2Functional name of contact pointZealand University Hospital
    B.5.3 Address:
    B.5.3.1Street AddressLykkebækvej 1
    B.5.3.2Town/ cityKøge
    B.5.3.3Post code4600
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4528526432
    B.5.6E-mailaslb@regionsjaelland.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name metronidazole “B. Braun”
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMetronidazole
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntestinal use
    Local use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETRONIDAZOLE
    D.3.9.3Other descriptive nameMetronidazole
    D.3.9.4EV Substance CodeSUB08922MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAntibiotic
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Infectofos®
    D.2.1.1.2Name of the Marketing Authorisation holderInfectopharm
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFosfomycin
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntestinal use
    Local use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFosfomycin disodium
    D.3.9.3Other descriptive nameFOSFOMYCIN DISODIUM
    D.3.9.4EV Substance CodeSUB127116
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAntibiotic
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Colon cancer in track 1.

    Colon adenoma in track 2.
    Koloncancer i spor 1.

    Kolonadenom i spor 2.
    E.1.1.1Medical condition in easily understood language
    Colon cancer in track 1.

    Colon adenoma in track 2.
    Tyktarmskræft i spor 1.

    Tyktarmsadenom i spor 2.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10009944
    E.1.2Term Colon cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10048832
    E.1.2Term Colon adenoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to investigate the effect of local antibiotic treatment with fosfomycin and metronidazole on tumor characteristics and the colonic biofilm in patients with right-sided colon cancer or right-sided colon adenomas.
    Formålet med dette studie er at undersøge effekten af lokal antibiotisk behandling med fosfomycin og metronidazol hos patienter med højresidig tyktarmskræft eller højresidig tyktarmsadenom.
    E.2.2Secondary objectives of the trial
    • Safety assessment of the spraying of the right hemicolon with fosfomycin/metronidazol gel.
    Sikkerhedsvurdering af det at spraye højre tyktarmsafsnit med fosfomycin/metronidazol gel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female patients above 18 years of age with either:
    • right-sided colon cancer tumor with adenocarcinoma histologically verified scheduled for open or laparoscopic resection at the Department of Surgery, Herlev Hospital or Zealand University Hospital (track 1)
    • right-sided adenomas ≥2cm in diameter endoscopically verified scheduled for endoscopic mucosal resection at the Department of Surgery, Herlev Hospital or Zealand University Hospital (track 2a)

    Written informed consent must be obtained.
    Mænd og kvinder over 18 år med enten:
    • Højresidig tyktarmskræfttumor, som er patologisk verificeret adenocarcinom, der skal have foretaget en åben eller laparoskopisk resektion ved Kirurgisk Afdeling, Herlev Hospital eller Sjællands Universitetshospital (track 1)
    • Højresidig tyktarmsadenom ≥2cm i diameter, som er endoskopisk verificeret,, der skal have foretaget en endoskopisk mukosaresektion ved Kirurgisk Afdeling, Herlev Hospital eller Sjællands Universitetshospital (track 2a)

    Informeret samtykke skal foreligge for alle deltagende patienter.
    E.4Principal exclusion criteria
    • Patients with previous allergic reaction to fosfomycin and/or metronidazole
    • Patients under current antibiotic treatment or patient who had the last dose of antibiotics 30 days prior to inclusion
    • Patients with a non-passable tumor or patients where a part of the tumor is not visible during endoscopy (Track 1)
    • Patients with neoadjuvant chemotherapy or radiation 12 months prior to the resection
    • Patients with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC)
    • Patients with a history of inflammatory bowel disease (IBD)
    • Patients under current treatment with warfarin (Marevan) and phenprocoumon (Marcoumar), or NOAK such as dabigatran (Pradaxa®), rivaroxiban (Xarelto®), edoxaban (Lixiana®) or apixaban (Eliquis®)
    • Patients under current treatment with Fenemal (Phenobarbital)
    • Patients who previously have received a fecal transplantation
    • Patients who have previously had colorectal cancer, and are now presenting with a secondary colon tumor
    • Patients with a current alcohol use disorder (AUD): defined as a patient who are currently drinking 8 or more drinks/week for women and 15 or more drinks/week for men
    • Predictable poor compliance (psychiatric disease, not speaking fluent Danish, mentally impaired etc)
    • Patients with an American Society of Anaesthesiologists physical status Classification (ASA score) of IV
    • Patients unable to be sedated
    • Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate)
    • Fertile women who do not use safe contraception during the study period
    Following contraceptive methods are acceptable when used consistently and in accordance with both the product label and the instructions of the physician are:
    - Oral contraceptive, either combined or progestogen alone
    - Injectable progestogen
    - Implants of levonorgestrel
    - Estrogenic vaginal ring
    - Percutaneous contraceptive patches
    - Intrauterine device or intrauterine system with a documented failure rate < 1% per year
    - Male partner sterilization (vasectomy with documented azoospermia) prior to female patient´s entry into the study, and this male is the sole partner for that patient
    - Double barrier method: condom with spermicidal agent (foam/gel/film/cream/suppository), condom and occlusive cap (diaphragm or cervical/vault cap) with vaginal spermicidal agent (foam/gel/film/cream/suppository)
    • Patienter med tidligere allergisk reaktion overfor fosfomycin og eller metronidazol
    • Patienter under antibiotisk behandling eller patienter med sidste antibiotikadosis 30 dage inden inklusion
    • Patienter, hvis tumor ej er passabel for endoskopet, eller hvor man ikke kan se hele tumor under endoskopien
    • Patienter med neoadjuverende kemoterapi eller stråling 12 måneder før operationen
    • Patienter, der er tidligere diagnosticeret med arvelige tyktarmskræftformer såsom familiær adenomatøs polypose (FAP) eller hereditær non-polypose coloncancer (HNPCC)
    • Patienter med tidligere inflammatorisk tarmsygdom (IBD)
    • Patienter i behandling med warfarin (Marevan) og phenprocoumon (Marcoumar), eller NOAK såsom dabigatran (Pradaxa®), rivaroxiban (Xarelto®), edoxaban (Lixiana®) eller apixaban (Eliquis®)
    • Patienter i behandling med Fenemal (phenobarbital)
    • Patienter, der tidligere har modtaget et fæcestransplantat
    • Patienter, der tidligere har haft en tyktarmskræft og som nu præsenterer sig med en sekundær (metakron) tyktarmstumor
    • Patienter med aktuel alkoholafhængighedssygdom (AUD): defineret som en patient, der aktuelt har et højt forbrug af på alcohol: 8 eller flere genstande per uge for kvinder og 15 eller flere genstande per uge for mænd
    • Patienter med forudset dårlig compliance (psykiatrisk lidelse,ej flydende dansk sprog etc)
    • Patienter med ASA klasse IV
    • Patienter, der ej kan sederes
    • Patienter, der er gravide eller ammende (fertile kvinder skal have en negativ serum-HCG eller urin-HCG inden deltagelse)
    • Fertile kvindelige patienter, der ikke anvender sikker prævention under studieperioden:
    o Oral prævention, enten kombinationspræparat eller progestogen
    o Injektion af progestogen
    o Implantat af levonorgestrel
    o Vaginal ring med østrogen
    o Perkutan præventionsplastre
    o Intrauterin prævention eller et intrauterint system med en dokumenteret failure rate < 1% pr år
    o Mandlig partner er steriliseret (vasektomi med dokumenteret azoospermi) inden deltagelse i studiet, og at denne partner er eneste partner for patienten
    o Dobbelt-barriere metode: kondom med spermicid agens (skum/gel/film/creme/suppositorie), kondom og kvindelig barriere (diaphragma eller cervical cap) med vaginal spermicid agens (skum/gel/film/creme/suppositorie)
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome
    • A quantitative change in the bacterial biomass adherent to the colonic epithelium of the resected colon adjusted for baseline level found before the intervention through fluorescence in situ (FISH) technique. The specific measurement variable is biofilm depth and 2D and 3D biofilm mass. The method of aggregation will be means.
    The exploratory primary outcomes
    • The determination of differences in translational markers present in the resected tumor tissue adjusted for the level seen at the baseline (the therapeutic colonoscopy) through a principal component analysis (PCA). The translational markers of interest are tumor markers, and markers of the microenvironment and the immune response. The analyses will be performed using the PanCancer IO 360TM Gene Expression Panel (nanoString).
    • The determination of a change in the bacterial composition adjusted for the bacteria found at baseline before the intervention through fluorescence in situ (FISH) technique and sequencing with Metagenome.
    Primære outcome:
    • En kvantitativ ændring af den bakterielle biomasse, der adhærerer til det resecerede tyktarmenafsnits epitel ved tumor justeret for baseline niveau inden antibiotikainterventionen ved fluorescence in situ hybridisering (FISH) teknik. De specifikke variable er biofilm tykkelse og 2D og 3D biofilm masse.

    Eksplorerende primære outcomes:
    • Det primære outcome er forskelle i translationelle markører tilstede i det resecerede tumor væv justeret for baseline niveau (inden den terapeutiske kikkertundersøgelse) gennem en principal component analyse (PCA). De translationelle markører er tumormarkører, markører for mikromiljøet og for immunresponset. Analyserne bliver foretaget med PanCancer IO 360TM Gene Expression Panel (nanoString).
    • En ændring i den bakterielle komposition i tumor justeret for baseline niveau inden antibiotikainterventionen ved fluorescence in situ hybridisering (FISH) teknik og vævssekventering med Metagenome.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary outcome
    A report with results from the biofilm depth analyses will be delivered when all samples have been analyzed.

    Exploratory primary outcome
    The results of the gene expression analysis of 770 genes will be delivered in a report. A report with results from the biofilm analyses will be delivered when all samples have been analyzed.
    Primære outcome: en raport med resultater for analyser af biofilmtykkelse og biomasse vil blive leveret når alle samples er analyseret.
    E.5.2Secondary end point(s)
    Track 1: colon cancer
    • Differences in the presence of known bacterial drivers such as Fusobacterium nucleatum, Enterococcus faecalis, Bacteroides Fragilis, Escherischia coli, and Porphyromonas in the tumor samples from preoperative biopsies and the resected colon.
    • Differences in gene expression in the normal mucosa from preoperative biopsies and the resected colon using the PanCancer IO 360TM Gene Expression Panel (nanoString).
    • Differences in gene expression in the preoperative and operative blood samples determined by the nCounter® PanCancer Immune Profiling Panel (nanoString).
    • The pathological assessment of tumor: tumor type, grade of dysplasia, TNVM-stage, MSI-status along with an assessment of the immunological response using the Immunoscore and an assessment of the biofilm present on the tumor.
    • The pathological assessment of the normal mucosa of the right hemicolon: presence of biofilm, dysplasia and inflammation.
    • Safety assessment of the spraying of the right hemicolon with fosfomycin/metronidazole gel. This will be assessed through adverse events at least 19 days after the intervention (postoperative day 14).

    Track 2: colon adenoma
    • Differences in gene expression in the normal mucosa from preoperative biopsies and the operative biopsies using the PanCancer IO 360TM Gene Expression Panel (nanoString).
    • Differences in gene expression in the tumor tissue from the mucosal resection compared with archived FFPE tumor tissue from patients with colon adenoma using the PanCancer IO 360TM Gene Expression Panel (nanoString).
    • Differences in gene expression in the preoperative blood samples and the blood samples taken on the operation day using the nCounter® PanCancer Immune Profiling Panel (nanoString).
    • The pathological assessment of polyp: type and size, along with an assessment of the immunological response and an assessment of the biofilm present on the polyp.
    • The pathological assessment of the normal mucosa of the right hemicolon: presence of biofilm, dysplasia and inflammation.
    • Safety assessment of the spraying of the right hemicolon with fosfomycin/metronidazole gel. This will be assessed through adverse events at least 19 days after the intervention (postoperative day 14).
    Track 1: colon cancer
    • Forskelle i tilstedeværelsen af kræftfremmende bakterier såsom Fusobacterium nucleatum, Enterococcus faecalis, Bacteroides Fragilis, Escherischia coli, og Porphyromonas fra biopsier taget før antibiotikainterventionen og efter, i form af vævsprøver tarmresektat .
    • Forskelle i genekspression i den raske tyktarmsslimhinde (mukosa) fra biopsier taget før interventionen og vævsprøver fra tarmresektatet ved analyse PanCancer IO 360TM Gene Expression Panel (nanoString).
    • Forskelle i genekspression i blod opsamlet før interventionen og efter interventionen (på operationsdagen) ved analyse med nCounter® PanCancer Immune Profiling Panel (nanoString).
    • Patologisk undersøgelse af kræfttumor: tumortype, dysplasigrad , TNVM-stadie, MSI-status, vurdering af immunologisk respons vha Immunoscore og om biofilm er tilstede på tumor.
    • Patologisk undersøgelse af rask tyktarmsslimhinde (mukosa): tilstedeværelse af biofilm, dysplasi, og inflammation
    • Sikkerhedsvurdering af det at spraye højre tyktarmsafsnit med fosfomycin/metronidazol gel

    Track 2: tyktarmsadenom
    • Forskelle i tilstedeværelsen af kræftfremmende bakterier såsom Fusobacterium nucleatum, Enterococcus faecalis, Bacteroides Fragilis, Escherischia coli, og Porphyromonas fra biopsier taget før antibiotikainterventionen og efter, i form af vævsprøver fra slimhinde og slimhinderesektat.
    • Forskelle i genekspression i den raske tyktarmsslimhinde (mukosa) fra biopsier taget før interventionen og de operative biopsier ved analyse med PanCancer IO 360TM Gene Expression Panel (nanoString).
    • Forskelle i genekspression i tumorvæv fra de den resercerede tyktarmsslimhinde sammenlignet med arkiveret FFPE tumorvæv fra patienter med tyktarmsadenom ved analyse med PanCancer IO 360TM Gene Expression Panel (nanoString).
    • Forskelle i genekspression i blod opsamlet før interventionen og efter interventionen (på operationsdagen) ved analyse med nCounter® PanCancer Immune Profiling Panel (nanoString).
    • Patologisk undersøgelse af adenoma: type og størrelse, vurdering af immunologisk respons og om biofilm er tilstede på adenomet
    • Patologisk undersøgelse af rask tyktarmsslimhinde (mukosa): tilstedeværelse af biofilm, dysplasi, og inflammation
    • Sikkerhedsvurdering af det at spraye højre tyktarmsafsnit med fosfomycin/metronidazol gel
    E.5.2.1Timepoint(s) of evaluation of this end point
    The study will collect demographic and baseline information from the patient files through Sundhedsplatformen (EPIC). The results of the gene expression analysis of 770 genes will be delivered in a report. A report with results from the biofilm analyses will be delivered when all samples have been analyzed. Immunoscore data will be delivered in a report. Data from pathology reports of the resected colon and resected mucosa will be collected from the pathology reports in Sundhedsplatformen. The results of the blood sample analyses will be collected through Sundhedsplatformen Safety assessment of the gel will be based on patient files as well as through the postoperative interview on postoperative day 14+/-2.
    Demografi og baseline information fra patientjournaler indsamles løbende fra Sundhedsplatformen sammen med patologisvar og blodprøvesvar. Resultater fra genekspressionsanalyserne af 770 gener og fra analyser af biofilm vil blive leveret når alle samples er analyseret. Sikkerhedsvudering af gelen vil blive foretaget løbende baseret på opslag i patientjournaler samt gennem de postoperative interviews på postoperative dag 14.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    translational biomarkers
    translationelle biomarkører
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Der er en matched retrospektiv kohorte af patienter med colonadenom, spor 2a
    There is a matched retrospective cohort of patients with colon adenoma, track 2a
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the 24th fully evaluable patient
    Sidste besøg for den 24. fuldt evaluerbare patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ingen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-06
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA