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Recruiting NCT02534649

Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials

No phase Interventional Solid Tumor Hematological Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Newly obtained biopsy and Blood samples collection.
Who it may be relevant to
Registry conditions: Solid Tumor, Hematological Malignancy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This is a biology driven, monocentric study designed to identify actionable molecular alterations in cancer patients with advanced disease. In this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling. Patients included in the BIP study and for whom a targetable genomic alteration had been identified might be subsequently included in an early phase trials running at Institut Bergonie or another French hospital.

Detailed description

The need to 'personalize' cancer therapy has been recognized, with specific biomarkers which will be used to direct targeted agents only to those patients deemed most likely to respond. This "personalized cancer medicine" requires two critical steps: first, a comprehensive assessment of the biological characteristics of tumors from each individual, and second, validated biomarkers to identify the subgroups of patients who are most likely to benefit from a given therapy and the next-generation sequencing provides unprecedented opportunities to draw a comprehensive picture of genetic aberrations involve in immunotherapy sensitivity and ultimately enable individualized treatment.

The main objective of this study is to use next generation sequencing technologies to identify actionable molecular alterations in cancer patients with advanced disease included in the study. This study will provide a fully integrated view of the molecular profile of the tumor for each patient included in the study. Such tumor profile will be used by clinicians to tailor therapies of patients in specific early phase clinical trials.

Interventions

  • Procedure Newly obtained biopsy and Blood samples collection
    For each patient: * Frozen and paraffin embedded tumor material (archival or new biopsy) will be obtained for genetic profiling * Four blood samples will be obtained for genetic profiling and assessment of markers The results of each tumor profile will be discussed within a multidisciplinary tumor board which aims at discussing the genomic profiles and at providing a therapeutic decision for each patient. Patients for whom no molecular aberration has been identified will be treated at the disc

Primary outcome measures

  • Proportion of patients presenting at least one genomic alteration [Time frame: 1 month]
Secondary outcome measures (3)
  • - Utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies) [Time frame: Utilization rates of molecular profiling information will be evaluated until the date of death from any cause, assessed up to 36 months]
  • Rate of molecular screening failure [Time frame: Molecular screening failure will be assessed at 1 month]
  • Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0. [Time frame: Safety will be assessed 1 month after biopsy]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years,
  • Histology: solid malignant tumor or hematological malignancy,
  • Deleted MSA9
  • Deleted MSA9,
  • Deleted MSA9,
  • Deleted MSA9,
  • Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code),
  • Voluntary signed and dated written informed consent prior to any study specific procedure.

Exclusion criteria

  • Deleted MSA9
  • Deleted MSA9
  • Deleted MSA9
  • Deleted MSA9
  • Deleted MSA9
  • Deleted MSA9
  • Deleted MSA9
  • Deleted MSA9
  • Individuals deprived of liberty or placed under guardianship
  • Pregnant or breast feeding women,
  • Previous enrolment in the present study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 7 centers
  • Centre Hospitalier de la Côte Basque — Bayonne
  • Clinique Tivoli-Ducos — Bordeaux
  • Institut Bergonie — Bordeaux
  • Polyclinique Bordeaux Nord Aquitaine — Bordeaux
  • Centre Hospitalier de Pau — Pau
  • Clinique Marzet — Pau
  • Centre Eugène Marquis — Rennes

Publications

  • Guegan JP, Peyraud F, Dadone-Montaudie B, Teyssonneau D, Palmieri LJ, Clot E, Cousin S, Roubaud G, Cabart M, Leroy L, Lebreton C, Rey C, Lara O, Odin O, Brunet M, Vanhersecke L, Gruyters EO, Achour I, Belcaid L, Le Moulec S, Grellety T, Bessede A, Italiano A. Analysis of PD1, LAG3, TIGIT, and TIM3 expression in human lung adenocarcinoma reveals a 25-gene signature predicting immunotherapy response PMID 39591972

Identifiers

NCT: NCT02534649 · IB2015-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗