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Study of the Immune Response in Colon Adenocarcinoma (IMCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015038
Recruitment Status : Not yet recruiting
First Posted : January 9, 2017
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
Innate Pharma
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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
Colon Adenocarcinoma

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Etude de la réponse Immunitaire Dans l'adénocarcinome Colique
Study Start Date : January 2017
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024



Primary Outcome Measures :
  1. Immune cells trafficking [ Time Frame: 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 [ Time Frame: Day 0 ]
    Histochemical method with a panel of Ab.

  2. 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) ]

Biospecimen Retention:   Samples With DNA
Tissu and blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with colon adenocarcinoma treated by surgery
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015038


Contacts
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Contact: Matthieu Allez, MD, PhD +33 1 42 49 95 97 matthieu.allez@aphp.fr

Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Innate Pharma
Investigators
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Principal Investigator: Matthieu Allez, MD, PhD Hopital Saint Louis
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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 ( Other Identifier: IDRCB )
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms