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

NCT01774409 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2024-03-04

No results posted yet for this study

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.

Conditions

  • Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Jean-Yves BLAY, MD PhD · Centre Leon Berard

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2025-07-31
Completion
2026-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01774409 on ClinicalTrials.gov