Exploring the relationship between the immune system and gastrointestinal cancers
Interaction Between Host, Microenvironment and Immunity on Gastrointestinal Neoplasms: A Retro-prospective Cohort Study
This study is trying to see how the immune system and the environment around tumors affect how long people with gastrointestinal cancers, like colorectal and pancreaticobiliary cancers, can survive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Boulogne-Billancourt) |
| Trial ID | NCT04363983 on ClinicalTrials.gov |
What this trial studies
This study investigates how the characteristics of the tumor microenvironment and the immune system affect the survival of patients with gastrointestinal cancers, particularly colorectal and pancreaticobiliary cancers. It includes a retrospective cohort of 150 patients diagnosed between 1998 and 2020 and a prospective cohort of 3000 patients diagnosed between 2020 and 2030, with a follow-up period of 10 years. The study will analyze molecular subgroups through DNA and RNA analysis, as well as assess the impact of host factors such as microbiota and metabolism on treatment response and tolerance. All treatment decisions will be made by the investigator physician based on established guidelines.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with diagnosed gastrointestinal cancers such as colorectal, pancreatic, biliary tract, or gastro-oesophageal tumors.
Not a fit: Patients who are under guardianship, foreign patients without proper medical coverage in France, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that improve survival rates and treatment responses for patients with gastrointestinal cancers.
How similar studies have performed: While the specific approach of this study may be novel, similar studies exploring the relationship between the immune system and cancer outcomes have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Carcinoma of colorectal, pancreatic, biliary tract or gastro-oesophageal, or neuroendocrine digestive tumors with cytologically or histologically proven, regardless of the stage; * Diagnosis between 1998 and 2030; * Be \>/= 18 years; * Have obtained signed informed consent (exemption for dead patients); * Affiliated to the French social security - welfare system in France (CMU included). Exclusion Criteria: * Patient under tutoraship or curatorship; * Foreign patient under AME schema, a medical help from the state in France; * Pregnant or breastfeeding women (for prospective study); * Any clinical, psychological or social reason which should influence patient compliance with protocol, according to investigator; * Patient refusal.
Where this trial is running
Boulogne-Billancourt
- Digestive Surgery Department, Ambroise Paré Hospital, APHP — Boulogne-Billancourt, France (Recruiting)
Study contacts
- Principal investigator: Frédérique PESCHAUD, MD, PhD — Digestive Surgery Department, Ambroise Paré Hospital, APHP
- Study coordinator: Frédérique PESCHAUD, MD, PhD
- Email: frederique.peschaud@aphp.fr
- Phone: +33 1 49 09 53 35
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.