Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms (CRC-ORGA2)

May 18, 2026 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

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
Time Frame
Percentage of viable organoids for 60 days of culture maintenance.
Time Frame: 60 days of culture maintenance.
60 days of culture maintenance.

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: GAEL ROTH, MD, PHD, University Hospital of Grenoble Alpes

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)

December 12, 2022

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A00793-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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