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

NCT06435689 | Not Yet Recruiting

• 1 other identifier: APHP231721
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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

Keywords

Organoids; T-cells; Metastasis; Immunotherapies

Outcome Measures

Primary Outcomes (1)

• Effectiveness of immunotherapies in a co-culture model

  Characterize effective immunotherapies in colorectal cancers by demonstrating their effectiveness in a co-culture model between cancer cells and autologous T cells.

  At 1 year

Secondary Outcomes (3)

• Evaluation of transcriptomic differences

  At 5 years

• Evaluation of proteomic differences

  At 5 years

• Evaluation of the T Cell Receptor (TCR) repertoire

  At 5 years

Study Arms (1)

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

Other: Sampling

Interventions

Sampling OTHER

Blood and surgical specimen sampling the day of surgery

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

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

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

You may qualify if:

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

You may not qualify if:

• Patient's opposition to research
• Patients under guardianship
• The following situations
• Persons unable to understand and/or read the information leaflet
• Patient with one of the following functions: Investigator or co-investigator, research assistant, pharmacist, study coordinator or, having any involvement in the study
• Non-cooperative or potentially non-compliant person for the study and its procedures with foreseeable difficulties in regular follow-up over 5 years.
• Non-affiliation with a social security scheme, Couverture Médicale Universelle or any equivalent scheme.
• Pregnant or breast-feeding women.
• HIV-positive patients.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital Saint Louis - gastoenterology

Paris, France

Location

Hôpital Saint Louis - visceral, oncological and endocrine surgery

Paris, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and surgical specimen sampling the day of surgery (primary tumor and metastases if applicable)

MeSH Terms

Conditions

Colonic Neoplasms; Neoplasm Metastasis

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thomas Aparicio, Pr

CONTACT

142499597; thomas.aparicio@aphp.fr

Jérôme Lambert, Pr

CONTACT

142499742; jerome.lambert@u-paris.fr

Study Design

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

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: May 30, 2024
• Study Start: June 15, 2024
• Primary Completion: June 15, 2025
• Study Completion (Estimated): June 15, 2039
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

FR (2)