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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2019-000935-15
    Sponsor's Protocol Code Number:PRODIGE70-CIRCULATE
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-19
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-000935-15
    A.3Full title of the trial
    CIRCULATE- CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
    CIRCULATE - Décision de traitement adjuvant des cancers coliques de stade II basée sur l’analyse de l’ADN tumoral circulant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CIRCULATE - A TRIAL TO IMPROVE CARE OF PATIENTS AFTER COLON TUMOR SURGERY, BASED ON AN INNOVATIVE MARKER: CIRCULATING TUMOR DNA
    CIRCULATE - un essai visant à améliorer la prise en charge des patients opérés de leur tumeur colique, basé sur un nouveau marqueur : l'ADN tumoral circulant
    A.3.2Name or abbreviated title of the trial where available
    PRODIGE 70-CIRCULATE
    PRODIGE 70-CIRCULATE
    A.4.1Sponsor's protocol code numberPRODIGE70-CIRCULATE
    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 SponsorCentre Hospitalier Universitaire (CHU) de Dijon
    B.1.3.4CountryFrance
    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 supportINCA-PHRC
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFédération Francophone de Cancérologie Digestive (FFCD)
    B.5.2Functional name of contact pointFlore Geillon
    B.5.3 Address:
    B.5.3.1Street AddressFaculté de Médecine, 7 Boulevard Jeanne d'Arc, BP 87900
    B.5.3.2Town/ cityDijon cedex
    B.5.3.3Post code21079
    B.5.3.4CountryFrance
    B.5.4Telephone number33380393404
    B.5.5Fax number33380381841
    B.5.6E-mailflore.geillon@u-bourgogne.fr
    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 Fluorouracile Ebewe
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number400
    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 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 Fluorouracile Ebewe
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2400
    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 No
    D.IMP: 3
    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 Eloxatine
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXALIPLATIN
    D.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeSUB09490MIG
    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 No
    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
    stage II colon cancer, after tumour resection
    cancer du colon de stade II, après résection de la tumeur
    E.1.1.1Medical condition in easily understood language
    patient with early care of their colon cancer, after complete surgery of the tumour
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to improve Disease Free Survival (DFS) of centralized ctDNA positive patients by the administration of FOLFOX6m adjuvant treatment. The primary endpoint of the study will be to improve 3-year DFS from 25% to 42.5% by the use of adjuvant chemotherapy
    L’objectif principal de l’étude est d’améliorer la Survie Sans Maladie de patients positifs au dépistage centralisé de l’ADNtc (ADNtc +), par l’administration d’une chimiothérapie adjuvante (FOLFOX6m). Le critère d'évaluation principal visé sera d’améliorer de 25% à 42,5% la Survie Sans Maladie (DFS « Disease Free Survival ») à 3 ans grâce à une chimiothérapie adjuvante.
    E.2.2Secondary objectives of the trial
    - To improve Time to recurrence (TTR) in ctDNA positive patients with adjuvant therapy versus without therapy
    - To improve Overall survival (OS) in ctDNA positive patients with adjuvant therapy versus without therapy
    - To compare DFS and OS in ctDNA positive versus ctDNA negative patients, without adjuvant treatment
    - To estimate Toxicities using NCI-CTC v4 classification in ctDNA positive patients with or without adjuvant therapy (to assess treatment tolerability in this population)
    - To improve the success rate of prognostication of stage II colo-rectal cancer by testing the added value of ctDNA on classical prognostic factors for colo-rectal cancer,To identify biological factors predictive of adjuvant treatment efficacy in ctDNA+ stage II colo-rectal cancer
    - Améliorer le temps jusqu’à récidive (TTR « Time To Recurrence » des patients ADNtc + par une chimiothérapie adjuvante versus sans chimiothérapie
    - Améliorer la Survie Globale (SG) des patients ADNtc + par une chimiothérapie adjuvante versus sans chimiothérapie
    - Comparer la DFS et la SG entre patients ADNtc + et patients ADNtc -, sans traitement adjuvant
    - Estimer les toxicités selon la classification du NCI-CTC (version 4.0), chez les patients ADNtc ayant reçu ou non un traitement adjuvant (afin d’analyser la tolérance du traitement dans cette population)
    - Améliorer le taux de réussite du pronostic du cancer du côlon de stade II en testant la valeur ajoutée de l’ADNtc aux valeurs pronostiques classiques.
    - Identifier les facteurs biologiques prédictifs de l'efficacité du traitement adjuvant dans le cancer du côlon de stade II chez des patients ADNtc +.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    On the collection of tumor samples (patients randomized and followed-up within study):
    - Analysis of main somatic mutations (KRAS, NRAS, BRAF, TP53, PIK3CA…),
    - Characterization of consensus molecular subtypes by gene expression measurement,
    - Characterization of the CIMP phenotype,
    - Characterization of mismatch repair deficiency,
    - DNA methylation profiling to establish precision medicine biomarkers.
    On the collection of plasma samples (patients randomized in arm “chemotherapy):
    - Evaluation of the value of ctDNA negativation during chemotherapy administration as a prognostic factor for DFS and OS.
    Sur les échantillons tumoraux (étude proposée aux patients randomisés et suivis dans le cadre de l’étude) :
    • Analyse des principales mutations somatiques (KRAS, NRAS, BRAF, TP53, PIK3CA...),
    • Caractérisation de profils moléculaires par mesure de l'expression de gènes,
    • Caractérisation du phénotype méthylateur (CIMP) dans le cancer colorectal,
    • Caractérisation des défauts de réparation de l’ADN corrigeant les erreurs d'appariement,
    • Établissement de profils de méthylation de l'ADN comme biomarqueurs au service d’une médecine de précision.
    Sur les échantillons sanguins (étude proposée aux patients randomisés dans le bras « Chimiothérapie ») :
    • Analyse de la négativation du niveau d’ADNtc après administration d’une chimiothérapie adjuvante, comme facteur pronostique de la DFS et de la SG.
    E.3Principal inclusion criteria
    - Signed written informed consent obtained prior to any study specific procedures
    - Age ≥ 18 years and ≤ 75 years
    - Histologically confirmed stage II colon and high rectum adenocarcinoma excluding low and medium rectal cancers (tumor location ≥ 12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery are still eligible), without gross or microscopic evidence of residual disease after surgery with curative intent. Pathology report must be faxed to CRGA just after patient’s registration.
    - No metastatic disease on CT-Scan and/or liver MRI done within 3 months before randomization.
    - Randomization planned up to 7 weeks after curative R0 resection
    - WHO performance Status < 2
    - No prior chemotherapy for colo-rectal cancer
    - No prior abdominal or pelvic irradiation for colo-rectal cancer
    - Life expectancy of ≥ 5 years
    - Negative pregnancy test performed ≤ 7 before registration (for women of childbearing age)
    - Adequate haematological function:with neutrophils ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL (5,6 mmol/l)
    - Total bilirubin ≤ 1.5 x ULN (upper limit of normal)
    - ASAT and ALAT ≤ 2.5 x ULN
    - Alkaline phosphatase ≤ 2.5 x ULN
    - Serum creatinine ≤ 120 µmol/L or creatinine clearance ≥50 ml/min according MDRD (Modification of Diet in Renal Disease)
    - Carcinoembryogenic antigen (CEA) ≤ 1.5 x ULN after surgery (during screening period)
    - Patient affiliated to a social security system
    - Consentement éclairé signé, obtenu préalablement à toute procédure spécifique à l’étude,
    - Age ≥ 18 ans et ≤ 75 ans,
    - Adénocarcinome de stade II du côlon ou du haut rectum histologiquement confirmé (sont exclus les cancers du bas et moyen rectum, mais sont éligibles les tumeurs avec une localisation par endoscopie ≥ à 12 cm de la marge anal et/ou au-dessus de la ligne de réflexion péritonéale lors de la chirurgie), sans évidence macroscopique ou microscopique de maladie résiduelle après une chirurgie avec intention curative. Le compte-rendu anatomopathologique ayant appuyé le diagnostic devra être faxé au CRGA après enregistrement du patient),
    - Absence de maladie métastatique détectée par CT-Scan et/ou par IRM hépatique, dans les 3 mois précédant la randomisation,
    - Randomisation planifiée dans les 7 semaines après résection curative de type R0,
    - Statut OMS < 2,
    - Absence de chimiothérapie antérieure pour traiter le cancer colorectal,
    - Absence d’irradiation abdominale ou pelvienne antérieure pour traiter le cancer colorectal,
    - Espérance de vie ≥ 5 ans,
    - Fonction hématologique adéquate : neutrophiles ≥ 1500 /mm3, numération plaquettaire ≥ 100 000 /mm3, hémoglobine ≥ 9 g/dL (≥ 5,6 mmol/L),
    - Bilirubine totale ≤ 1,5 x LSN (Limite Supérieure de la Normale),
    - ASAT et ALAT ≤ 2,5 x LSN,
    - Phosphatase alcaline ≤ 2,5 x LSN,
    - Créatinine sérique ≤ 120 µmol/L ou clairance de la créatinine ≥50 mL/min selon la formule MDRD (« Modification of the Diet in Renal Disease »),
    - Antigène carcino-embryonnaire (ACE) ≤ 1,5 x LSN après résection (pendant la période de screening clinique),
    - Test de grossesse négatif dans les 7 jours précédant l'enregistrement (pour les femmes en âge de procréer),
    - Patient affilié à un système de sécurité sociale.
    E.4Principal exclusion criteria
    - T4b tumors
    - Peripheral neuropathy > grade 1
    - Comorbidity influencing the 5 year patients’ survival including clinically relevant cardiovascular disease
    - Ischemic myocardial infarction in the last year and/or unstable ischemic cardiopathy,
    - Participation to another interventional study for postoperative therapy
    - Known DPD deficiency (for patients afterward randomized in chemotherapy arm, DPD deficiency will be mandatory tested prior to 5FU administration)
    - Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to sign the informed consent or to finish the study
    - Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥ 5 years,
    - Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women. Women of childbearing potential should agree to use a method of contraception during treatment of the trial and at least 4 months after discontinuation of oxaliplatin therapy and at least 30 days after discontinuation of 5-fluorouracil. Men must agree to use a method of contraception during treatment and at least 6 months after stopping oxaliplatin therapy and at least 3 months after stopping 5-fluorouracil.
    - Tumeurs T4b,
    - Neuropathie périphérique de grade > 1 (selon NCI-CTC v4.0),
    - Présence de facteurs de comorbidité pouvant influencer la survie des patients à 5 ans, y compris les maladies cardiovasculaires cliniquement pertinentes,
    - Infarctus du myocarde au cours de la dernière année et/ou cardiopathie ischémique instable,
    - Participation à une autre étude interventionnelle pour la thérapie postopératoire,
    - Déficit connu en DPD (pour les patients randomisés par la suite dans le bras « Chimiothérapie », le déficit en DPD sera obligatoirement testé avant administration de 5FU ou capécitabine et le résultat du dépistage devra être immédiatement faxé au CRGA),
    - Incapacité légale ou tout état physique, psychologique, social ou géographique susceptible d’entraver la capacité du patient à signer le consentement éclairé et/ou à coopérer et participer à l’étude,
    - Antécédent médicaux de cancer, ou cancer concomitant, à l’exception du cancer in-situ du col de l’utérus et des cancers cutanés (basocellulaire ou spinocellulaire) traités et contrôlés, ou de cancer en rémission complète depuis au moins 5 ans,
    - Absence de contraception efficace chez les patients en âge de procréer, les femmes enceintes ou allaitantes. Les femmes en âge de procréer s’engagent à utiliser une méthode contraceptive pendant le traitement à essai et au moins 4 mois après l'arrêt de l’oxaliplatine et 30 jours après l'arrêt du 5-fluorouracile. Les hommes s’engagent à utiliser une méthode contraceptive pendant le traitement à l’essai et au moins 6 mois après l'arrêt de l’oxaliplatine et 3 mois après l'arrêt du 5-fluorouracile.
    E.5 End points
    E.5.1Primary end point(s)
    To improve 3-year DFS in ctDNA positive patients from 25 % to 42.5 % by the use of adjuvant oxaliplatin (HR:0.61). Historically the 5-year OS was the traditional endpoint for clinical trials of adjuvant colon cancer treatment. The ACCENT meta-analysis demonstrated that 3-year DFS was an excellent surrogate of 5-year OS [1]. Since this publication, 3-year DFS is the endpoint for adjuvant trials in colon cancer.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 years after last patient randomisation
    E.5.2Secondary end point(s)
    - Safety: Toxicities will be graded according to the NCI-CTCAE v 4.0 criteria before each cycle.
    - OS: will be defined as the time between randomization date and death (any cause). Patients alive will be censored at date of last news.
    - TTR: will be defined as time from randomization to first event (i.e, first recurrence local or metastatic) or death linked to disease recurrence. Patients alive without event will be censored at the date of the last follow-up. Patients with second colorectal cancer or death form any cause will be censored at the date of the event
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years after last patient randomisation
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard follow-up process
    E.8.2.4Number of treatment arms in the trial3
    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 concerned100
    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 last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 1800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state1980
    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)
    After the subject has ended the participation in the trial, follow-up of the patient will continue according to recommendations of "Thesaurus National de Cancérologie Digestive"
    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 Decision2019-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-10
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 04:00:36 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA