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

NCT ID: NCT01774409

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2026-07-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Blood and tumor samples

Group Type: EXPERIMENTAL

Blood and tumor samples

Intervention Type: GENETIC

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.

Interventions

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.

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of advanced (locally-advanced or metastatic) malignant tumor of any histological type
• Tumor sample available to determine the genetic profile: either archival tumor sample [FFPE (formalin fixed and paraffin embedded)] or perform a new biopsy on an accessible lesion (left at the investigator's appreciation). For biopsies, presence of at least one tumor lesion with a diameter ≥ 20 mm, visible by medical imaging and accessible to repeatable percutaneous (needle biopsies 18 gauge or larger) sampling that permit core needle biopsy (ideally 4 cores) without unacceptable risk of a major procedural complication. Please note that brain and bone lesions are not considered as accessible lesions.
• Patient with 1st, 2nd or 3rd line therapy (NB: endocrine therapy (monotherapy) are not considered as line therapy) for advanced / metastatic cancer.
• For patients over 70 years of age, a Performance Status (PS) of 0 on the ECOG scale.
• Patient must be covered by a medical insurance.
• Informed consent signed by the patient and/or by parents (or legal representative) for patients below 18.

Exclusion Criteria

• No tumor sample available.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Yves BLAY, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

Centre Hospitalier Annecy Genevois

Annecy, , France

Site Status: RECRUITING

Groupement Hospitalier Mutualiste

Grenoble, , France

Site Status: RECRUITING

Hôpital Edouard Herriot

Lyon, , France

Site Status: NOT_YET_RECRUITING

Centre Léon Bérard

Lyon, , France

Site Status: RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status: ACTIVE_NOT_RECRUITING

CHU de Saint-Etienne Hôpital Nord

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-Yves BLAY, MD

Role: CONTACT

jean-yves.blay@lyon.unicancer.fr

+33 4 78 78 51 26

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Other Identifiers

ET12-082

Identifier Type: OTHER

Identifier Source: secondary_id

PROFILER

Identifier Type: -

Identifier Source: org_study_id