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

Not Applicable

Active, not recruiting

• Conditions: Metastatic Oncogen-driven Cancer
• Interventions: Procedure: Biopsy

• Registration Number: NCT02517892
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-18
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-04
• Study First Posted: 2015-08-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Patients diagnosed with confirmed cancer and who fulfill the following eligibility criteria will be considered eligible for this study:

1. Patient affiliated to a social security regimen
2. Patients scheduled to receive anticancer agents or currently receiving anticancer agents
3. Tumor lesion accessible to core biopsies (malignant effusions can represent an alternative)
4. Patient who is fully informed, able to comply with the protocol and who signed the informed consent.
5. 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.

Exclusion Criteria

1. Coagulation abnormality prohibiting a biopsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with metastatic oncogen-driven cancer	Biopsy	-

Primary Outcome Measures

Name	Time	Method
Type and frequency of molecular alterations in resistant tumors using whole exome sequencing	30 days after inclusion

Trial Locations

Locations (1)

Gustave Roussy Cancer Campus Grand Paris; 🇫🇷 Villejuif, Val De Marne, France