Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer

It is a non-randomized, multicentric, cohort study, combined with a biological sample collection, a clinical data collection and with a genetic and immunologic biomarkers study. The ProfiLER program aims to implement a personalized cancer medicine approach by proposing to establish the genetic and immunologic profile of the tumor for patients with an advanced malignant tumor, in order to define a map of genetic (for the pre-identified target genes) and immunologic profiles for all the studied types of cancer. This study will also allow adapting the therapeutic management of these patients, if needed, by giving them targeted therapies or immunotherapies (commercialized on in ongoing clinical trials), based on the recommendations of the multidisciplinary molecular board. The genetic and immunologic profile of the tumor will be determined from archival or fresh collected (biopsy of a reachable lesion) tumor sample and from a blood sample. The correlation between genetic profiles of the tumor, patients immunity status and clinical data (progression, tumor response, etc.) collected from the patient medical records will probably allow us to identify biomarkers with a potential predictive value and to determine if some genetic disorders are linked to immunity status alterations.

NCT Number	NCT01774409
Lead Sponsor	Centre Leon Berard
Conditions	Neoplasms
Enrollment	10,000 participants
Start Date	2013-02
Primary Completion	2025-07 (estimated)
Study Completion	2026-07 (estimated)
Updated on ClinicalTrials.gov	2024-03-04