Molecular screening for advanced pancreatic cancer patients
A Single-center, Prospective Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
NA · Centre Leon Berard · NCT05380414
This study is testing if analyzing tumor and blood samples from patients with advanced pancreatic cancer can help doctors choose the best personalized treatment options before they start their first round of therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Leon Berard (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05380414 on ClinicalTrials.gov |
What this trial studies
This program aims to implement molecular screening for patients with advanced or metastatic pancreatic cancer prior to starting their first line of treatment. By analyzing tumor and blood samples, the study seeks to identify genomic and transcriptomic profiles that can guide personalized medicine approaches. The goal is to better select patients for targeted therapies and combinations with chemotherapy, potentially improving treatment outcomes. The study focuses on patients who have received limited prior systemic chemotherapy and have accessible archival tumor samples.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with metastatic or advanced pancreatic ductal adenocarcinoma who have had no more than one prior systemic chemotherapy.
Not a fit: Patients with curative therapy options available or those with additional malignancies requiring active treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective personalized treatment options for patients with advanced pancreatic cancer.
How similar studies have performed: Other studies have shown promise in using molecular profiling for personalized treatment in various cancers, suggesting potential success for this approach in pancreatic cancer as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patient \> 18 years * metastatic or advanced PDAC * Patient pretreated with no more than one prior systemic chemotherapy for metastatic/advanced disease (radiotherapy is not counted as a line of therapy). * Availability of an archival representative FFPE tumor sample from primary tumor (surgery or diagnostic biopsy) and/or from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block. * Life expectancy \> 3 months * PS score 0 or 1. Exclusion Criteria: * Curative therapy available * Any condition contraindicated with blood sampling procedures required by the protocol. * Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer. * Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
Where this trial is running
Lyon
- Centre Léon Bérard — Lyon, France (RECRUITING)
Study contacts
- Principal investigator: Philippe CASSIER, MD, PhD — Centre Leon Berard
- Study coordinator: Philippe CASSIER, MD, PhD
- Email: philippe.cassier@lyon.unicancer.fr
- Phone: 0426556833
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.
Conditions: Metastatic Pancreatic Cancer, Advanced Pancreatic Cancer, Molecular screening, Genomic profiles, Transcriptomic profiles