Clinical trial
Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer
Name
PROFILER
Description
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.
Trial arms
Trial start
2013-02-01
Estimated PCD
2025-07-01
Trial end
2026-07-01
Status
Recruiting
Treatment
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.
Arms:
Blood and tumor samples
Size
10000
Primary endpoint
Establish a map of genetic profiles (for the pre-identified target genes) for all types of advanced malignant tumors.
at least 3 years after patient enrollment
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10000, 'type': 'ESTIMATED'}}
Updated at
2024-03-04
1 organization
Organization
Centre Leon Berard