Study and Modulation of Immune Responses in Primary and Metastatic Colon Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sampling.
- Who it may be relevant to
- Registry conditions: Colon Cancer, Peritoneal Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Etude et Modulation de la réponse Immunitaire Dans Les Cancers COlorectaux Primaires et METastatiques
Overview
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.
Interventions
- Other Sampling
Blood and surgical specimen sampling the day of surgery
Primary outcome measures
- Effectiveness of immunotherapies in a co-culture model [Time frame: At 1 year]
Secondary outcome measures (3)
- Evaluation of transcriptomic differences [Time frame: At 5 years]
- Evaluation of proteomic differences [Time frame: At 5 years]
- Evaluation of the T Cell Receptor (TCR) repertoire [Time frame: At 5 years]
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Hôpital Saint Louis - gastoenterology — Paris
- Hôpital Saint Louis - visceral, oncological and endocrine surgery — Paris
Identifiers
NCT: NCT06435689 · APHP231721