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

NCT ID: NCT02517892

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-18

Study Completion Date

2025-03-31

Brief Summary

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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

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Conditions

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Metastatic Oncogen-driven Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with metastatic oncogen-driven cancer

Group Type EXPERIMENTAL

Biopsy

Intervention Type PROCEDURE

Interventions

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Biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val De Marne, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 40027306 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38433714 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37364000 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35872509 (View on PubMed)

Other Identifiers

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2014/2144

Identifier Type: OTHER

Identifier Source: secondary_id

2014-A01147-40

Identifier Type: -

Identifier Source: org_study_id

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