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IMCO: Study of the Immune Response in Colon Adenocarcinoma

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03015038
Collaborator
Innate Pharma (Industry)
100
Enrollment
1
Location
83.8
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Duration of each part of the study per patient:

  • Screening: From 1 to 4 weeks

  • Sampling period (blood and tissue): 1 day

  • Follow-up by patient: 60 months

  • Total study duration by patient: 84 months

  • Total inclusion duration: 24 months

  • Total Follow-up duration: 60 months

  • Total study duration: 84 months

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Etude de la réponse Immunitaire Dans l'adénocarcinome Colique
    Actual Study Start Date :
    Feb 5, 2017
    Anticipated Primary Completion Date :
    Feb 1, 2024
    Anticipated Study Completion Date :
    Feb 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Immune cells trafficking [Day 0]

      Frequency of T cells in the blood and tissue (Flow cytometry method with a panel of Ab).

    Secondary Outcome Measures

    1. Infiltration of leucocytes in tumor tissue [Day 0]

      Histochemical method with a panel of Ab.

    2. Safety (Number of adverse events, ECOG status) [After Day 0 until the end of the study (Month 3, Month 6, Month 9, Month 12, Month 15, Month 18,Month 21, Month 24, Month 30, Month 36, Month 42, Month 48, Month 54 and Month 60)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients aged 18 or more.

    2. Affiliation to a social security scheme

    3. Diagnosis of a colon adenocarcinoma.

    4. Patient have signed and dated consent of the study before undertaking procedures related to the study.

    Exclusion Criteria:

    1. Patients under guardianship / curatorship

    2. Following Situations

    • Persons unable to understand, read and / or sign an informed consent

    • Patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study

    • Uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year.

    • No affiliation to a social security scheme, a universal medical coverage or any similar plan.

    1. Pregnant or lactating women.

    2. Patients with HIV seropositivity.

    3. Rectal tumor location.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Saint Louis Paris France 75000

    Sponsors and Collaborators

    • Institut National de la Santé Et de la Recherche Médicale, France
    • Innate Pharma

    Investigators

    • Principal Investigator: Matthieu Allez, MD, PhD, Hopital Saint Louis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut National de la Santé Et de la Recherche Médicale, France
    ClinicalTrials.gov Identifier:
    NCT03015038
    Other Study ID Numbers:
    • C16-21
    • 2016-A01102-49
    First Posted:
    Jan 9, 2017
    Last Update Posted:
    Aug 26, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of Aug 26, 2021