NCT06435689Not yet recruiting
Study and Modulation of Immune Responses in Primary and Metastatic Colon Cancers
Etude et Modulation de la réponse Immunitaire Dans Les Cancers COlorectaux Primaires et METastatiques
Source: ClinicalTrials.gov · Last updated 30 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 26 May 2024
- Start date
- 15 Jun 2024
- Primary completion date
- 15 Jun 2025
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Colorectal cancer
- NCT number
- NCT06435689
What you commit to
- Study type: Observational
- Planned participants: 500
- From 15 Jun 2024 to the primary completion date, 15 Jun 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- HIV-positive patients.
Other
- 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.
Who the study is looking for
- Male or female 18 years of age or older
- Diagnosis of colorectal adenocarcinoma
- Scheduled resection of tumor and/or metastasis(es)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Saint Louis - gastoenterology Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Saint Louis - visceral, oncological and endocrine surgery Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.