A Prospective Trial to Study the Evolution of Clonal Arch... | NCT02517892

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

NCT02517892

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Completed

Last Update Posted

Jun 24, 2025Actual

Enrollment

1,500Actual

Phase

Not Applicable

Conditions

Metastatic Oncogen-driven Cancer

Interventions

Biopsy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014/2144	Other Identifier	CSET number

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2014Actual

Primary Completion Date

Mar 2025Actual

Completion Date

Mar 2025Actual

First Submitted Date

Aug 3, 2015

First Submission Date that Met QC Criteria

Aug 4, 2015

First Posted Date

Aug 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2025

Last Update Posted Date

Jun 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Actual

Label	Type	Description	Intervention Names
Patients with metastatic oncogen-driven cancer	Experimental		Procedure: Biopsy

Name	Type	Description	Arm Group Labels	Other Names
Biopsy	Procedure		Patients with metastatic oncogen-driven cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Type and frequency of molecular alterations in resistant tumors using whole exome sequencing		30 days after inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Exclusion Criteria:

1. Coagulation abnormality prohibiting a biopsy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gustave Roussy Cancer Campus Grand Paris		Villejuif	Val De Marne	94805	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40027306	Derived	Parisi C, Benitez JC, Lecourt H, dall'Olio FG, Aldea M, Blanc-Durand F, Verge V, Quivoron C, Naltet C, Abdayem P, Lavaud P, Ghigna MR, Friboulet L, Loriot Y, De Botton S, Ribrag V, Ardizzoni A, Planchard D, Soria JC, Barlesi F, Besse B. Anti-ALK autoantibodies in patients with ALK-positive Non-Small Cell Lung Cancer (NSCLC): A monocentric experience. J Liq Biopsy. 2024 Jul 30;6:100164. doi: 10.1016/j.jlb.2024.100164. eCollection 2024 Dec.
38433714

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures