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    Summary
    EudraCT Number:2015-000467-14
    Sponsor's Protocol Code Number:IEO223
    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:2020-12-18
    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 number2015-000467-14
    A.3Full title of the trial
    Colorectal cancer, Vitamina D and microbiota: towards new preventive strategies. A double blind Phase II randomized trial, ColoViD
    Microbiota, vitamina D e tumori del colon retto: verso nuove possibili strategie di prevenzione. Studio randomizzato di fase II in doppio cieco ColoviD/placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The role of the gut flora and vitamin D for the of colorectal cancer prevention with vitamin D supplementation.
    Il ruolo della flora batterica intestinale e della vitamina D per la prevenzione dei tumori del colon con supplementazione di vitamina D.
    A.3.2Name or abbreviated title of the trial where available
    COLOVID
    COLOVID
    A.4.1Sponsor's protocol code numberIEO223
    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 SponsorISTITUTO EUROPEO DI ONCOLOGIA
    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 supportAIRC
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Europeo di Oncologia
    B.5.2Functional name of contact pointUfficio studi clinici
    B.5.3 Address:
    B.5.3.1Street AddressVia Adamello 16
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20139
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 57489848
    B.5.5Fax number+39 02 57489781
    B.5.6E-mailufficio.studiclinici@ieo.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 DIBASE - 10.000 UI/ML GOCCE ORALI, SOLUZIONE FLACONE CON GONTACOCCE 10 ML
    D.2.1.1.2Name of the Marketing Authorisation holderABIOGEN PHARMA 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 nameDIBASE
    D.3.4Pharmaceutical form Oral drops, solution
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.8.4Route 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
    Colon rectal cancer stage I - III
    Carcinoma del colon retto stadio I - III
    E.1.1.1Medical condition in easily understood language
    Colon rectal cancer
    Carcinoma del colon retto
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10001171
    E.1.2Term Adenocarcinoma of colon stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10001170
    E.1.2Term Adenocarcinoma of colon stage II
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10001169
    E.1.2Term Adenocarcinoma of colon stage I
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Change of microbiota profile after 1 year of vitamin D supplementation.
    modificazione della composizione del microbiota dopo intervento con vitamina D, in pazienti operati di tumore al colon-retto stadio I-III.
    E.2.2Secondary objectives of the trial
    ¿ microbiota composition may interact with vitamin D supplementation in changing 25(OH)D serum level.
    ¿ Microbiota and vitamin D status in association with CRC stage and Ki67 expression.
    ¿ VDR, vitamin D binding protein (serum DBP and GC) polymorphism, CYP 27A1 and CYP24A1 polymorphisms and their possible interferences on vitamin D and microbiota interaction.
    ¿ Valutazione dell¿interazione tra microbiota e livelli sierici di vitamina D dopo supplementazione
    ¿ Valutazione del microbiota e i livelli di vitamina D associati all¿espressione del Ki67 e allo stadio di malattia
    ¿ Valutazione dell¿associazione dei polimorfismi del VDR, GC e CYP24A1 e CYP27A1 con livelli di vit. D, il microbiota e lo stadio di malattia alla diagnosi;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 35-75 years old patients ;
    2. Resected colorectal cancer stage I - III in the last 24 months
    3. Signed informed Consent according to ICH-GCP;
    4. Willingness to provide stool, blood samples;
    5. Performance Status of 0-1 (ECOG);
    1. Età compresa tra 35-75 anni;
    2. Carcinoma colon-rettale stage: I - II asportato radicalmente asportato negli ultimi 24 mesi;
    3. Consenso informato firmato;
    4. Disponibilità a donare i campioni di sangue e feci;
    5. Performance Status 0-1 (ECOG)
    E.4Principal exclusion criteria
    1. History of cancer in the prior five years (other than CIN and NMSC);
    2. Clinical/radiological evidence or laboratory/pathology report of residual neoplasia or recurrence;
    3. Carrier of a pathogenetic mutation for the main syndrome for colorectal cancer (FAP, Lynch, other);
    4. Vitamin D level = 30 ng/ml;
    5. Current daily supplementation of vitamin D (e.g. calcium citrate with vitamin D);
    6. History of recurrent renal calculi
    7. History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, Crohn disease, any chronic IBD);
    8. Chronic liver disease and/or renal disease with alterated biochemical functions, or renal dialysis; = grade 2 based on CTCAE (v 4.0);
    9. Pregnancy or breast feeding or planning on becoming pregnant during the study;
    10. Known chronic alcoholism;
    11. Known hypersensitivity to vitamin D;
    12. Any medical condition that in the physician’s opinion would potentially interfere with the subjects’ health.
    1. Pregressa diagnosi di tumore maligno nei precedenti 5 anni (esclusa CIN3 e carcinoma baso-cellulare);

    2. evidenza di malattia residua o metastatica (clinico/radiologico/laboratoristico);
    3. Concomitante supplementazione con vitamina D ad una dose > di 400 IU die
    4. Storia di calcoli renali ricorrenti
    5. Uso orale, attuale o cronico, di corticosteroidi;
    6. Diagnosi di malattie da malassorbimento (es.. celiachia, malattia di Crohn, retto colite ulcerosa, insufficienza pancreatica);
    7. Malattie croniche epatiche e renali con funzionalità alterata = grado II;
    8. Malattia alle paratiroidi e sarcoidosi;
    9. Gravidanza o allattamento in atto e nei precedenti tre mesi;
    10. Alcolismo;
    11. Qualunque altra condizione clinica o psichica che a giudizio dello sperimentatore controindichi la partecipazione allo studio;
    12. Presenza di = 10 polipi alla colonscopia basale, o se non garantita la bonifica dei polipi presenti.
    E.5 End points
    E.5.1Primary end point(s)
    bacterial composition modification after 1 year of vitamin D administration
    modificazione della composizione batterica dopo un anno di somministrazione di vitamina D
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of a 12 months treatment period
    al termine dei 12 mesi di trattamento
    E.5.2Secondary end point(s)
    whether Vitamin D receptors, GC and serum level of 25(OH)D, at baseline, are associated with colorectal cancer prognostic factors; whether microbiota composition is associated with colorectal cancer prognostic factors; changes in proliferation evaluated by Ki67 LI on the primary tumor and normal rectal mucosa pre and post treatment; Comparison of lumen and adherent mucosal microbiota composition
    Se i recettori della vitamina D. GC e i livelli sierici di 25(OH)D al baseline siano associati a fattori prognostici di carcinoma del colonretto; Se la composizione microbiota ¿ associata a fattori prognostici di carcinoma del colon retto; Modifiche nella proliferazione valutati tramite KI67 LI su tumore primario e mucosa rettale pre e post trattamento; Confronto tra il microbiota fecale e quello adeso alla mucosa
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months from the end of the treatment of the last patient enrolled
    ; 6 months from the end of the treatment of the last patient enrolled; 6 months from the end of the treatment of the last patient enrolled; 6 months from the end of the treatment of the last patient enrolled
    6 mesi dalla fine del trattamento dell¿ultimo paziente arruolato
    ; 6 mesi dalla fine del trattamento dell¿ultimo paziente arruolato; 6 mesi dalla fine del trattamento dell¿ultimo paziente arruolato; 6 mesi dalla fine del trattamento dell¿ultimo paziente arruolato
    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 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 No
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    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: 59
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state104
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 104
    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
    nessuno
    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 Decision2015-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-02-25
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