A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents

Gustave Roussy, Cancer Campus, Grand Paris1 site in 1 country1,500 target enrollmentDecember 18, 2014

ConditionsMetastatic Oncogen-driven Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic Oncogen-driven Cancer
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Enrollment: 1500
Locations: 1
Primary Endpoint: Type and frequency of molecular alterations in resistant tumors using whole exome sequencing
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective study to identify molecular mechanisms of acquired resistance to targeted therapies in patients with unresectable or metastatic cancer.

This is a protocol to study clinical characteristics and biopsy tissue of patients with oncogene-driven cancer who have had previous clinical response to targeted therapy and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of acquired resistance to targeted therapies.

Registry

clinicaltrials.gov

Start Date

December 18, 2014

End Date

March 1, 2025

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients diagnosed with confirmed cancer and who fulfill the following eligibility criteria will be considered eligible for this study:
•Patient affiliated to a social security regimen
•Patients scheduled to receive anticancer agents or currently receiving anticancer agents
•Tumor lesion accessible to core biopsies (malignant effusions can represent an alternative)
•Patient who is fully informed, able to comply with the protocol and who signed the informed consent.
•Availability of initial tumor material (ideally frozen, or non-Bouin fixed paraffin embedded material) acquired before exposure to the targeted therapy Note: Patients may have received other treatments since treatment with targeted therapies including radiation or chemotherapy, before undergoing the study biopsy.