At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed advanced (locally-advanced or metastatic) malignant tumor of any histological type
- ✓Tumor sample available for genetic profiling (archival FFPE or new biopsy)
- ✓For new biopsy: at least one accessible lesion ≥20 mm diameter accessible to percutaneous needle biopsy (18 gauge or larger)
- ✓1st, 2nd, or 3rd line therapy for advanced/metastatic cancer (endocrine monotherapy not counted)
- ✕Brain and bone lesions not considered accessible for biopsy
- ✕No tumor sample available
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT01774409N/ARecruitingUpdate OverdueUpdated 27mo ago · Completion was 12mo agoProgram to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer
In Brief
A clinical study evaluating Blood and tumor samples for Neoplasms. Currently recruiting, targeting 10,000 participants across 6 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
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.