Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer
18 Years
N/A
Both
Neoplasms
Trial Information
Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer
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
Retrospective clinical data collection:
Patients' clinical data will be collected retrospectively 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.
Inclusion Criteria:
- Age ≥ 18 years
- Histologically or cytologically confirmed diagnosis of the advanced malignant tumor
of any histological type (locally advanced tumor)
Tumor sample available to determine the genetic profile:
- either archival tumor sample if available [frozen or FFPE (formalin fixed and
paraffin embedded) AND with no progression of the disease since the last treatment;
- or perform a new biopsy on a reachable lesion (determined by the oncologist and/or
the radiologist) to collect a fresh sample if no sample is available OR in case of
progressive disease. Especially for this case, the establishment of the genetic
profile must be performed on a tumor sample which corresponds to the disease stage
during the last treatment.
- Patient must be covered by a medical insurance.
- Informed consent signed.
Exclusion Criteria:
- No archival tumor sample available and non-biopsiable disease.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Establish a map of genetic profiles (for the pre-identified target genes) for all types of advanced malignant tumors.
Outcome Description:
Description of the incidence rates of each detected genetic disorder among the pre-identified target genes in the global cohort and for each histological type.
Outcome Time Frame:
3 years after first patient enrollment
Safety Issue:
No
Principal Investigator
Jean-Yves BLAY, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Léon Bérard
Authority:
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study ID:
PROFILER
NCT ID:
NCT01774409
Start Date:
February 2013
Completion Date:
March 2016
Related Keywords:
- Neoplasms
- all advanced malignant tumor
- Neoplasms
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