Study and Modulation of Immune Responses in Primary and Metastatic Colon Cancers

NCT ID: NCT06435689

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2039-06-15

Brief Summary

Colorectal cancer (CRC) is the 3rd most common cancer in France. Treatment of CRC relies primarily on surgical removal of the primary tumor and chemotherapy is the current standard of care for synchronous metastatic disease. Overall survival remains strongly correlated with the tumor stage at the time of surgery, from 90% at five years for localized disease (stages 1 and 2), to around 20% for metastatic forms of the disease (stage 4). Recent research in cancer highlights the role of the immune system in the development, evolution and fate of tumors. Understanding the nature of interactions between different immune cells infiltrating the tumor is important for the development of innovative therapies. Recently, the consensus molecular classification of CRC confirmed the importance of the immune response in CRC by showing that a "high immune response" is a good prognostic indicator for patients with this pathology. However, immunotherapies are effective for only a minority of patients with metastatic CRC. Indeed, anti Programmed cell Death 1 (anti-PD-1), -PD-L1 immune checkpoint blocking antibodies have only shown effectiveness in patients with microsatellite instability (MSI), which only represents 5% of metastatic CRCs.

Thus, the aim of this study is to better understand the role of the immune system on the development of CRC and its possible modulation to treat or prevent metastatic recurrences.

Conditions

Colon Cancer; Peritoneal Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing surgery for the treatment of primary and/or metastatic colorectal cancers

Sampling

Intervention Type: OTHER

Blood and surgical specimen sampling the day of surgery

Interventions

Sampling

Blood and surgical specimen sampling the day of surgery

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female 18 years of age or older
• Diagnosis of colorectal adenocarcinoma
• Scheduled resection of tumor and/or metastasis(es)

Exclusion Criteria

• Patient's opposition to research
• Patients under guardianship
• The following situations

1. Persons unable to understand and/or read the information leaflet

2. Patient with one of the following functions: Investigator or co-investigator, research assistant, pharmacist, study coordinator or, having any involvement in the study

3. Non-cooperative or potentially non-compliant person for the study and its procedures with foreseeable difficulties in regular follow-up over 5 years.

4. Non-affiliation with a social security scheme, Couverture Médicale Universelle or any equivalent scheme.

• Pregnant or breast-feeding women.
• HIV-positive patients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Saint Louis - gastoenterology

Paris, , France

Hôpital Saint Louis - visceral, oncological and endocrine surgery

Paris, , France

Countries

France

Central Contacts

Thomas Aparicio, Pr

Role: CONTACT

thomas.aparicio@aphp.fr

142499597 ext. +33

Jérôme Lambert, Pr

Role: CONTACT

jerome.lambert@u-paris.fr

142499742 ext. +33

Facility Contacts

Thomas Aparicio, Pr

Role: primary

thomas.aparicio@aphp.fr

Diane Goéré, Pr

Role: primary

diane.goere@aphp.fr

Other Identifiers

APHP231721

Identifier Type: -

Identifier Source: org_study_id