NCT01774409

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,000 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Determination of the tumor profile and review in multidisciplinary molecular board: The genetic and immunologic profile will be performed from the available tumor sample and from a blood sample. Genetic profile: * Research of mutations/insertions/deletions for an array of predefined genes in tumor deoxyribonucleic acid by high-throughput sequencing * Analysis of copy number variations of genes on tumor deoxyribonucleic acid by microarray-based comparative genomic hybridization * Analysis of rearrangements involving the gene Anaplastic Lymphoma Kinase that can't be detected by Next Generation Sequencing or array Comparative Genomic Hybridization (balanced translocations) by means of fluorescent hybridization probes on tumor samples Immunologic profile: analysis of the expression of relevant immunologic markers Clinical data collection: Patients' clinical data will be collected from the patient medical record. This study is not a treatment evaluation. Patients' follow-up and treatment will be performed according to the center local practices or to the specificities of a clinical trial in which the patient would have been enrolled, depending on the recommendations given by the multidisciplinary molecular board, with the review of the tumor genetic profile.

Conditions

• Neoplasms

Interventions

Type	Name	Description
GENETIC	Blood and tumor samples	Genetic: Establishment of the genetic and immunologic profile Whole blood sampling : * 1 tube for the constitutional DNA extraction; * 3 tubes for ancillary studies and research. Collection of the available archival tumor sample (frozen or FFPE). If there's no available sample, the investigator will prescribe a biopsy of a reachable lesion. With the established profile, recommendations will be given by a multidisciplinary molecular board.

Timeline

• Start date: 2013-02-01
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2013-01-24
• Last updated: 2024-03-04

Locations

6 sites across 1 country: France