Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms

Primary Tumor Clinical Trial

— CRC-ORGA2  

Official title:

Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms: a Patient-derived Tumoroids Prospective Collection From Systemic Treatment Naive Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05038358
• Other study ID #: 2021-A00793-38
• Status: Recruiting
• Start date: December 12, 2022
• Est. completion date: September 30, 2026

Study information

• Verified date: November 2023
• Source: University Hospital, Grenoble
• Contact: GAEL ROTH, MD, PHD
• Phone: 04 76 76 51 68
• Email: GRoth[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Colon Tumor
• Neoplasms
• Primary Tumor

Locations

Country	Name	City	State
France	University Hospital of Grenoble Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of viable organoids for 60 days of culture maintenance.		60 days of culture maintenance.