Collection of blood samples from patients with metastatic digestive cancers
Development of a Prospective Clinicobiological Database in Metastatic Digestive Cancers
This study is collecting blood samples from patients with advanced digestive cancers to see if they can help create better, personalized treatment plans.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Drugs / interventions | chemotherapy, trastuzumab |
| Locations | 1 site (Montpellier, Hérault) |
| Trial ID | NCT03978078 on ClinicalTrials.gov |
What this trial studies
This study aims to create a comprehensive collection of blood samples from patients diagnosed with metastatic digestive adenocarcinoma, specifically during their first and second lines of chemotherapy and/or targeted therapy. The samples will be utilized for research projects focused on developing personalized management strategies for these patients. The study addresses the current limitations in identifying biomarkers that can predict treatment responses and monitor efficacy, which are crucial for improving patient outcomes. By collecting samples before and during treatment, the research seeks to enhance understanding of resistance mechanisms and treatment effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed adenocarcinoma of the digestive system who are about to begin first or second line metastatic chemotherapy or targeted therapy.
Not a fit: Patients who are under 18 years old, have non-adenocarcinoma histological types, or are currently receiving specific treatments in the metastatic lines may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with metastatic digestive cancers.
How similar studies have performed: Other studies have shown promise in utilizing biological samples for developing targeted therapies, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female ≥ 18 years old 2. Histological documentation of adenocarcinoma of the colon or rectum, small intestine, pancreas, stomach, bile duct, oesophagus 3. Patient who will receive a first or second line metastatic chemotherapy and/or targeted therapy 4. Informed consent form (ICF) signed Exclusion Criteria: 1. Male or female \< 18 years old 2. Non-adenocarcinoma histological type 3. Patient already undergoing specific treatment (chemotherapy and/or targeted therapy) in 1st or 2nd metastatic line 4. Pregnant and/or breastfeeding woman 5. Patient not affiliated to a social security system 6. Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons 7. Patient who is included in a Phase I-II therapeutic trial modifying usual management and involving additional and specific blood samples
Where this trial is running
Montpellier, Hérault
- Institut régional du cancer de Montpellier — Montpellier, Hérault, France (Recruiting)
Study contacts
- Study coordinator: Aurore MOUSSION
- Email: jean-pierre.bleuse@icm.unicancer.fr
- Phone: 4 67 61 31 02
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.