Study of the Immune Response in Colon Adenocarcinoma (IMCO)

August 25, 2021 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Etude de la réponse Immunitaire Dans l'adénocarcinome Colique

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

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75000
        • Hopital Saint Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with colon adenocarcinoma treated by surgery

Description

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.
  3. Pregnant or lactating women.
  4. Patients with HIV seropositivity.
  5. Rectal tumor location.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune cells trafficking
Time Frame: Day 0
Frequency of T cells in the blood and tissue (Flow cytometry method with a panel of Ab).
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infiltration of leucocytes in tumor tissue
Time Frame: Day 0
Histochemical method with a panel of Ab.
Day 0
Safety (Number of adverse events, ECOG status)
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Innate Pharma

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2017

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimate)

January 9, 2017

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C16-21
  • 2016-A01102-49 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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