Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms

NCT05038358 | Recruiting

• 1 other identifier: 2021-A00793-38
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is the third most common cancer worldwide and its progression-free survival is still low, around 10 months. Thirthy to 50% of patients do not respond to chemotherapy upon initiation of treatment, suggesting that early development of chemoresistance mechanisms remains a major challenge. In order to better characterize these mechanisms, the aim is to develop a model of tumoroids derived from patients with a colorectal tumors prior to any systemic anti cancer treatment. This project will both allow us to study the role of the immunological microenvironment in chemoresistance and identify new predictive markers of tumor response. It will then serve to develop innovative personalized medicine strategies by targeting the newly identified mechanisms. This study should in fine help to improve the cancer patient's care.

Conditions

Primary Tumor; Colon Tumor

Keywords

Organoid collection from fresh human primary colonic tumor tissue

Outcome Measures

Primary Outcomes (1)

• Percentage of viable organoids for 60 days of culture maintenance.

  60 days of culture maintenance.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

colorectal adenocarcinoma, naive from neo-adjuvant chemotherapy, indication of surgical resection

You may qualify if:

• Male and female over 18 years old.
• Managed at the CHUGA for a colorectal adenocarcinoma
• With an indication for immediate surgical resection as part of the care.
• Patient naive from neo-adjuvant chemotherapy
• Patient did not object to the CRC-ORGA-2 study

You may not qualify if:

• Patients protected by law (pregnant or breastfeeding women, minors, patients under guardianship or trusteeship, persons deprived of their liberty or hospitalized under duress).
• Patients with positive HIV, HBV, HCV serology.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital of Grenoble Alpes

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• GAEL ROTH, MD, PHD

  university hospital of Grenoble alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GAEL ROTH, MD, PHD

CONTACT

04 76 76 51 68; GRoth@chu-grenoble.fr

ARNAUD MILLET, MD, PHD

CONTACT

arnaud.millet@inserm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 9, 2021
• Study Start: December 12, 2022
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

FR (1)