Study of the Immune Response in Colon Adenocarcinoma

Colon Adenocarcinoma Clinical Trial

— IMCO  

Official title:

Etude de la réponse Immunitaire Dans l'adénocarcinome Colique

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03015038
• Other study ID #: C16-21
• Secondary ID: 2016-A01102-49
• Status: Active, not recruiting
• Start date: February 5, 2017
• Est. completion date: February 2024

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Colon Adenocarcinoma

Locations

Country	Name	City	State
France	Hôpital Saint Louis	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Innate Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune cells trafficking	Frequency of T cells in the blood and tissue (Flow cytometry method with a panel of Ab).	Day 0
Secondary	Infiltration of leucocytes in tumor tissue	Histochemical method with a panel of Ab.	Day 0
Secondary	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)