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

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02517892
• Collaborator: (none)
• Enrollment: 1,500
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 95.4
• Patients Per Site Per Month: 15.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Oncogen-driven Cancer	Procedure: Biopsy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents
• Actual Study Start Date: Dec 18, 2014
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with metastatic oncogen-driven cancer	Procedure: Biopsy

Outcome Measures

Primary Outcome Measures

1. Type and frequency of molecular alterations in resistant tumors using whole exome sequencing [30 days after inclusion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gustave Roussy Cancer Campus Grand Paris	Villejuif	Val De Marne	France	94805

Sponsors and Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
• ClinicalTrials.gov Identifier: NCT02517892
• Other Study ID Numbers: 2014-A01147-40; 2014/2144
• First Posted: Aug 7, 2015
• Last Update Posted: Feb 25, 2021
• Last Verified: Feb 1, 2021

Study Results

No Results Posted as of Feb 25, 2021