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

NCT02517892 | Completed

• 2 other identifiers: 2014-A01147-402014/2144
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Oncogen-driven Cancer

Outcome Measures

Primary Outcomes (1)

• Type and frequency of molecular alterations in resistant tumors using whole exome sequencing

  30 days after inclusion

Study Arms (1)

Patients with metastatic oncogen-driven cancer

EXPERIMENTAL

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

Patients with metastatic oncogen-driven cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Coagulation abnormality prohibiting a biopsy

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val De Marne, 94805, France

Location

Related Publications (4)

• 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.

  PMID: 40027306 DERIVED

• Bigot L, Sabio J, Poiraudeau L, Annereau M, Menssouri N, Helissey C, Deas O, Aglave M, Ibrahim T, Pobel C, Nobre C, Nicotra C, Ngo-Camus M, Lacroix L, Rouleau E, Tselikas L, Judde JG, Chauchereau A, Bernard-Tessier A, Patrikidou A, Naoun N, Flippot R, Colomba E, Fuerea A, Albiges L, Lavaud P, Massard C, Friboulet L, Fizazi K, Besse B, Scoazec JY, Loriot Y. Development of Novel Models of Aggressive Variants of Castration-resistant Prostate Cancer. Eur Urol Oncol. 2024 Jun;7(3):527-536. doi: 10.1016/j.euo.2023.10.011. Epub 2023 Oct 27.

  PMID: 38433714 DERIVED

• Menssouri N, Poiraudeau L, Helissey C, Bigot L, Sabio J, Ibrahim T, Pobel C, Nicotra C, Ngo-Camus M, Lacroix L, Rouleau E, Tselikas L, Chauchereau A, Blanc-Durand F, Bernard-Tessier A, Patrikidou A, Naoun N, Flippot R, Colomba E, Fuerea A, Albiges L, Lavaud P, van de Wiel P, den Biezen E, Wesseling-Rozendaal Y, Ponce S, Michiels S, Massard C, Gautheret D, Barlesi F, Andre F, Besse B, Scoazec JY, Friboulet L, Fizazi K, Loriot Y. Genomic Profiling of Metastatic Castration-Resistant Prostate Cancer Samples Resistant to Androgen Receptor Pathway Inhibitors. Clin Cancer Res. 2023 Nov 1;29(21):4504-4517. doi: 10.1158/1078-0432.CCR-22-3736.

  PMID: 37364000 DERIVED

• Martin-Romano P, Colmet-Daage L, Morel D, Baldini C, Verlingue L, Bahleda R, Gazzah A, Champiat S, Varga A, Michot JM, Ngo-Camus M, Nicotra C, Marabelle A, Soria JC, Rouleau E, Lacroix L, Hollebecque A, Massard C, Postel-Vinay S. Epigenetic gene alterations in metastatic solid tumours: results from the prospective precision medicine MOSCATO and MATCH-R trials. Eur J Cancer. 2022 Sep;173:133-145. doi: 10.1016/j.ejca.2022.06.014. Epub 2022 Jul 21.

  PMID: 35872509 DERIVED

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 7, 2015
• Study Start: December 18, 2014
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

FR (1)