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    Summary
    EudraCT Number:2015-004824-77
    Sponsor's Protocol Code Number:27UCS2015
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-01-20
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-004824-77
    A.3Full title of the trial
    A randomized, phase II, double-blind, placebo-controlled, multicenter, 2x2 factorial design biomarker tertiary prevention trial of low-dose aspirin and metformin in resected stage I-III colorectal cancer patients. The ASAMET Trial
    Studio randomizzato con disegno 2x2 fattoriale, di fase II, in doppio cieco, controllato con placebo, multicentrico, di prevenzione terziaria per valutare la modulazione di biomarcatori in pazienti operati di cancro del colon-retto, stadio I-III, trattati con aspirina a basso dosaggio e metformina.Studio ASAMET.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A biomarker tertiary prevention trial of low-dose aspirin and metformin in stage I-III colorectal cancer patients. The ASAMET Trial
    Studio di prevenzione terziaria per valutare la modulazione di biomarcatori in pazienti affetti da cancro del colon-retto, stadio I-III, trattati con aspirina a basso dosaggio e metformina.Studio ASAMET.
    A.3.2Name or abbreviated title of the trial where available
    ASAMET
    ASAMET
    A.4.1Sponsor's protocol code number27UCS2015
    A.5.4Other Identifiers
    Name:ASAMETNumber:27UCS2015
    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 SponsorENTE OSPEDALIERO OSPEDALI GALLIERA
    B.1.3.4CountryItaly
    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 supportMinistero della Salute
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEnte Ospedaliero Ospedali Galliera
    B.5.2Functional name of contact pointUfficio del Coordinatore Scientific
    B.5.3 Address:
    B.5.3.1Street AddressVia Volta 8
    B.5.3.2Town/ cityGenova
    B.5.3.3Post code16128
    B.5.3.4CountryItaly
    B.5.4Telephone number0039 0105634188
    B.5.5Fax number0039 0105634201
    B.5.6E-mailucs@galliera.it
    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 CARDIOASPIRIN - 100 MG COMPRESSE GASTRORESISTENTI30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameAspirina
    D.3.2Product code B01AC06
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 No
    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 METFORAL - 850 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORI GUIDOTTI S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameMETFORAL 850 mg compresse rivestite con film
    D.3.2Product code 019449038
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Surgical resected colorectal cancer (stage I-III)
    Cancro al colon-retto operato (Stadio I-III)
    E.1.1.1Medical condition in easily understood language
    Surgical resected colorectal cancer (stage I-III)
    Cancro al colon-retto operato (Stadio I-III)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    To test the synergistic effect of the combined treatment with low dose ASA plus MET given for 1 year to reduce the expression of NFκB (primary endpoint) in unaffected colonic tissue in patients with removed CRC.
    Testare ad un anno l'effetto sinergico del trattamento combinato con ASA a basse dosi e MET in pazienti operati di tumore al colon, nel ridurre l’espressione del biomarcatore NFκB nel tessuto sano dei pazienti. L’endpoint primario è definito come la differenza nei livelli di espressione di NFκB post- e pre-trattamento.
    E.2.2Secondary objectives of the trial
    To test the effect of treatment with ASA and MET, in combination and independently, on the following secondary endpoints:
    •The change in IHC expression levels of pS6K, p53, beta-catenin, PI3K
    •The change in the circulating biomarkers IL-6, CRP, VEGF and HOMA index
    •The gene expression levels of candidate genes , pathways and genome-wide expression profile in colon unaffected biopsy tissue.
    To define the blood and tissue drug levels of metformin,
    • To genetically characterize the primary colorectal carcinomas using NGS
    and determine their association with treatment response.
    •To study the treatment tolerability comparing incidence and grade of toxicities among arms
    •To study the serum concentrations of TBx as a biomarker of treatment adherence,to be correlated with biomarker modulation and toxicity.
    •To evaluate the effect of treatment on psychological variables and cancer related fatigue.
    •La differenza (post-pretrattamento) nei livelli di espressione di pS6K, p53, beta-catenina, PI3K, nel tessuto sano dei pazienti;
    •La differenza nei livelli circolanti di IL-6, CRP, VEGF e indice HOMA
    •La modulazione dell’espressione genica di un set di geni candidati e coinvolti nel processo di cancerogenesi, pathways e il profilo genomico nel tessuto sano dei pazienti;
    • Determinare i livelli di MET nel sangue e nel tessuto sano
    • Caratterizzare geneticamente il tumore colorettale primitivo attraverso sequenziamento NGS in associazione alla risposta al trattamento.
    • Studiare la tollerabilità del trattamento confrontando l’incidenza e il grado di tossicità per ogni braccio di trattamento;
    • Studiare le concentrazioni seriche di TxB2 come biomarcatore di aderenza al trattamento da correlare con la modulazione dei biomarker e la tossicità.
    • Valutare l'effetto del trattamento sulle variabili psicologiche, stili di vita e sui sintomi associati al cancro


    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    "A randomized, 2x2 biomarker prevention trial of low-dose aspirin and metformin in colon cancer patients." V0_18th december 2015
    1-Metabolome analysis: the change of low molecular weight compounds in serum samples (up to 53 analytes) to obtain a signature of response to therapy.
    2-The 12 month change of microbial composition by sequencing of the 16S rRNA gene of the colorectal microbiota by NGS analysis in colonic tissue and faeces.
    -The 12 month change in autoantibody compositions in serum samples (ASMA, AMA, APCA, ANA, ANCA, ASCA, ENA/dsDNA, TPO) by ELISA,chemoluminescence and immunoblotting assays.
    4-To evaluate the interactions between treatment and physical activity, life style and food habits on the endpoint biomarkers.
    Studio randomizzato di prevenzione, 2X2 fattoriale, in pazienti operati di cancro al colon trattati con basse dosi di aspirina e metformina" V0_18 dicembre 2015
    1-Analisi Metabolomica: dopo 1 anno di trattamento, valutazione delle differenze dei livelli ematici pre- e post-trattamento di composti a basso peso molecolare tra cui citochine e fattori di crescita (circa 53 analiti) per ottenere una mappatura di risposta al trattamento a seconda del braccio di randomizzazione.
    2-Valutazione del cambiamento, dopo 1 anno di trattamento, della composizione microbica sul tessuto e nelle feci mediante il sequenziamento del gene 16S rRNA del Microbiota colorettale con analisi NGS.
    3-Studio del cambiamento, dopo 1 anno di trattamento, della composizione di autoanticorpi in campioni di siero (ASMA, AMA, APCA, ANA, ANCA, ASCA, ENA/dsDNA, TPO) attraverso ELISA, chemiluminescenza e saggi di immunoblotting.
    4- Valutare l'interazione tra trattamento e attività fisica, stili di vita e abitudini alimentari sugli endpoint.
    E.3Principal inclusion criteria
    Patients aged > 18 and ≤ 80 years.
    • Patients with completely resected stage I, II, or III primary colorectal cancer within 24 months prior to randomization, regardless of (neo-)adjuvant chemotherapy. Patientswith pT1 CRC treated with endoscopic polypectomy.
    • Adjuvant chemotherapy and (neo)adjuvant radiotherapy terminated at least 3 months before randomization.
    • ECOG performance status ≤ 1.
    • Satisfactory hematological and biochemical functions:
    o Platelets ≥ 100 x 10^9/L
    o Creatinine clearance estimated with the Cockcroft - Gault formula ≥ 60 mL/min. Patients with Gault formula ≥ 45-59 ≤ ml/min are eligible but they will receive a single (evening) tablet of MET, 850 mg.
    o AST and ALT ≤ 2.5 times ULN.
    • Females of childbearing potential/males with partners of childbearing potential participating in the study are to use effective methods of birth control during study participation. Female participants must provide a pregnancy test, according to local national guidelines.
    • Able to understand and sign an informed consent (or have a legal representative who is able and willing to do so).
    Pazienti di età >18 e ≤ 80 anni, operati di tumore al colon-retto (stadi I-III) entro 2 anni dalla randomizzazione, indipendentemente dalla terapia (neo-)adiuvante effettuata;
    • Pazienti con tumore in stadio pT1 trattati con polipectomia endoscopica.
    • Chemioterapia adiuvante e radioterapia
    (neo-)adiuvante terminata al massimo entro 3 mesi dalla randomizzazione;
    • ECOG performance status ≤1.
    • Funzionalità ematologica, epatica e renale che soddisfi i seguenti criteri:
    o Piastrine ≥ 100 x 10^9/L
    o Clearance della creatinine calcolata con la formula di Crockcroft – Gault ≥ 45 mL/min. I pazienti con valori ≥ 45-60 ≤ ml/min sono eleggibili ma riceveranno una singola compressa di MET (850 mg) alla sera.
    o AST e ALT ≤ 2.5 volte ULN.
    • Le donne in età fertile dovranno utilizzare efficaci metodi di contraccezione durante tutta la partecipazione allo studio;
    • Capacità di comprendere e firmare un consenso informato (o di avere un rappresentante legale che sia in grado e disposto a farlo).

    E.4Principal exclusion criteria
    Patients who are not able to undergo colonoscopy.
    • Patients who are allergic or intolerant to ibuprofen or naproxen, or who have MET-, or ASA-, or salicylate intolerance or more generalized drug intolerance to non-steroidal anti-inflammatory drugs (NSAIDs).
    • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing or participating in the study and/or comply with study procedures.
    • Chronic treatment with ASA or other NSAIDs or MET or patients who are on current long term treatment (≥ 4 consecutive weeks) with ASA, NSAID or COX -2 inhibitors or MET.
    • Diabetic patients on drug treatment are excluded.
    • Anticoagulant therapy (dicumarol, heparin, fondaparinux, apixaban, dabigatran etexilate, rivaroxaban) or active current treatment with antiplatelet agents (e.g. off-study ASA, clopidogrel, prasugrel, ticagrelor, or ticlopidine).
    • Any other invasive malignancies (with the exclusion of basal cell carcinoma or cutaneous squamous cell carcinoma) diagnosed during the last 5 years before randomization.
    • Past history of any other invasive CRC than the one the patient is currently being treated for
    • Alcohol or drug abuse, defined according to Investigators discretion.
    • Prior history of gastro-intestinal bleeding to ASA or hemorrhagic diathesis (e.g. hemophilia).
    • Erosive-ulcerative lesions in the gastrointestinal tract
    • History of erosive GERD or active erosive GERD on gastroscopy.
    • Concomitant corticosteroid treatment.
    • Known hypersensitivity or intolerance to MET or ASA or NSAID.
    • Known deficiency of glucose-6-phosphate dehydrogenase (G6PD).
    • Treatment with another investigational drug < 28 days prior to study entry.
    • Concurrent participation in a clinical trial with the same endpoints.
    • History of hemorrhagic stroke.
    • Lynch Syndrome (HNPCC).
    • Crohn's disease (CD) and Ulcerative Colitis (UC).
    • Pregnant or lactating females.
    • History of lactic acidosis.
    • Liver dysfunction including chronic active hepatitis and cirrhosis not compensated.
    • History of vitamin B12 deficiency or megaloblastic anemia.
    • Uncontrolled coronary syndrome or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification).
    • Inability or unwillingness to swallow tablets.
    Qualsiasi condizione medica grave, anomalia di laboratorio o malattia psichiatrica che impedisse al soggetto la firma del consenso e/o la partecipazione allo studio e/o essere aderenti alle procedure previste dallo studio;
    • Pazienti in trattamento cronico o a lungo termine in corso (≥ 4 settimane consecutive) con ASA o altri FANS o MET o inibitori di COX-2 o MET.
    • Sono esclusi i pazienti diabetici in trattamento farmacologico.
    • Pazienti in terapia anticoagulante (dicumarolo, eparina, fondaparinux, apixaban, dabigatran etexilate, rivaroxaban) o in trattamento attivoco agenti antipiastrinici (es: ASA, clopidogrel, prasugrel, ticagrelor, or ticlopidine);
    • Presenza di altre neoplasie concomitati (ad esclusione di carcinoma delle cellule basali o del carcinoma squamoso cutaneo) diagnosticate nei 5 anni precedenti la randomizzazione;
    • Abuso di alcool o droghe;
    • Precedenti episodi di sanguinamento gastrointestinale a seguito di somministrazione di ASA odiatesi emorragica (emofilia);
    • Presenza di lesioni erosivo-ulcerative del tratto gastrointestinale;
    • Diagnosi (precedente o attuale) di malattia da reflusso gastroesofageo (GERD) a seguito di gastroscopia;
    • In trattamento con corticosteroidi;
    • Accertata ipersensibilità o intolleranza a MET o ASA o, in genere, a NSAID;
    • Accertata deficienza della Glucosio-6-fosfato deidrogenasi (G6PD);
    • Trattamento con altro farmaco sperimentale nei 28 giorni precedenti all’entrata in studio;
    • Storia precedente di ictus emorragico;
    • cancro colo-rettale ereditario non poliposico (HNPCC) o sindrome di Lynch (Lynch Syndrome);
    • Morbo di Crohn e Colite Ulcerosa;
    • Donne in gravidanza o allattamento;
    • Storia precedente di acidosi lattica;
    • Disfunzione epatica inclusa epatite cronica attiva e cirrosi non compensata;
    • Storia di carenza di vitamina B12o anemia megaloblastica;
    • Sindrome coronarica incontrollata o insufficienza cardiaca congestizia sintomatica (classe III oIV, New York Heart Association's Functional Classification).
    • Incapacità o mancanza di volontà di deglutire le compresse
    E.5 End points
    E.5.1Primary end point(s)
    To test the synergistic effect of the combined treatment with low dose ASA plus MET given for 1 year to reduce the expression of NFκB (primary endpoint) in unaffected colonic tissue in patients with removed CRC.
    Testare ad un anno l'effetto sinergico del trattamento combinato con ASA a basse dosi e MET in pazienti operati di tumore al colon, nel ridurre l’espressione del biomarcatore NFκB nel tessuto sano dei pazienti. L’endpoint primario è definito come la differenza nei livelli di espressione di NFκB post- e pre-trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    To test the effect of treatment with ASA and MET, in combination and independently, on the following secondary endpoints: •The change in IHC expression levels of pS6K, p53, beta-catenin, PI3K •The change in the circulating biomarkers IL-6, CRP, VEGF and HOMA index •The gene expression levels of candidate genes , pathways and genome-wide expression profile in colon unaffected biopsy tissue. To define the blood and tissue drug levels of metformin, 3. To genetically characterize the primary colorectal carcinomas using NGS and determine their association with treatment response. 4. To study the treatment tolerability comparing incidence and grade of toxicities among arms 5. To study the serum concentrations of TBx as a biomarker of treatment adherence,to be correlated with biomarker modulation and toxicity. 6. To evaluate the effect of treatment on psychological variables and cancer related fatigue.
    La differenza (post-pretrattamento) nei livelli di espressione di pS6K, p53, beta-catenina, PI3K, nel tessuto sano dei pazienti; •La differenza nei livelli circolanti di IL-6, CRP, VEGF e indice HOMA •La modulazione dell’espressione genica di un set di geni candidati e coinvolti nel processo di cancerogenesi, pathways e il profilo genomico nel tessuto sano dei pazienti; 2) Determinare i livelli di MET nel sangue e nel tessuto sano 3) Caratterizzare geneticamente il tumore colorettale primitivo attraverso sequenziamento NGS in associazione alla risposta al trattamento. 4) Studiare la tollerabilità del trattamento confrontando l’incidenza e il grado di tossicità per ogni braccio di trattamento; 5) Studiare le concentrazioni seriche di TxB2 come biomarcatore di aderenza al trattamento da correlare con la modulazione dei biomarker e la tossicità. 6) Valutare l'effetto del trattamento sulle variabili psicologiche, stili di vita e sui sintomi associati al cancro
    E.5.2.1Timepoint(s) of evaluation of this end point
    T0 (basal), T1 (12 months of treatment)
    T0 (basale), T1 (12 mesi di trattamento)
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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
    tertiary prevention
    prevenzione terziaria
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    2X2 fattoriale
    2X2 factorial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Slovenia
    E.8.7Trial has a data monitoring committee No
    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
    6 months after the LVLS (for last patient Biomarker Assessment, Data Cleaning & Data Base Closure)
    6 mesi dopo la LVLS (per messa a punto delle ultime valutazioni dei biomarcatori, data cleaning e chiusura del DB)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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)
    No follow-up has been designed. Patients enrolled will be followed in clinical practice after ended their partecipation in the trial.
    lo studio non prevede un follow-up. I pazienti arruolati, al termine dello studio,saranno seguiti in pratica clinica
    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 Decision2016-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2024-10-15
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