Molecular Screening for Cancer Treatment Optimization

NCT ID: NCT01566019

Last Updated: 2020-02-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

2150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-28

Study Completion Date

2020-10-31

Brief Summary

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The primary objective of the study is to use high throughput molecular analysis (CGH Array and sequencing) to treat patients with metastatic cancer with targeted therapeutics in order to improve the progression free survival compared to the previous treatment line.

The secondary objectives are to investigate clinical practical feasibility of such technics, to potentially improve the overall survival of patients and to describe molecular portrait of Phase 1 candidates.

Detailed Description

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Conditions

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Metastatic Solid Tumors (Any Localization)

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 non curable metastatic cancer

Group Type EXPERIMENTAL

Tumoral biopsy

Intervention Type PROCEDURE

Every enrolled patient undergoes tumoral biopsy

Interventions

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Tumoral biopsy

Every enrolled patient undergoes tumoral biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Solid tumors ; Stade IV ; Local relapse or metastatic ; Uncurable
* Age \> 6 months
* PS 0/1 or Lansky play scale \>= 70%
* Minimum one treatment line, no limit in the prior number of treatment line
* Evaluable or measurable disease

Exclusion Criteria

* Life expectancy \< 3 months
* Carcinomatous meningitis
* Symptomatic or progressive radiologic brain metastasis for non-CNS tumors
* Polynuclear neutrophil \< 1 x 10\^9/L
* Platelets \< 100 x 10\^9/L
* Hemoglobin \< 90 g/L
* ALT/AST \> 2.5 N
* bilirubin \> 1.5 N
* Creatinine \>1.5 N
* Calcemia \> ULN
* Phosphate \> ULN
* Coagulation anomaly non-indicated for biopsy
Minimum Eligible Age

6 Months

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

Principal Investigators

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Jean-Charles SORIA, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave Roussy

Villejuif, Val De Marne, France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Jean-Charles SORIA, MD, PhD

Role: primary

+33 1 42 11 42 96

Christophe MASSARD, MD

Role: backup

+33 04 42 11 52 10

References

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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)

Verlingue L, Hollebecque A, Lacroix L, Postel-Vinay S, Varga A, El Dakdouki Y, Baldini C, Balheda R, Gazzah A, Michot JM, Marabelle A, Mir O, Arnedos M, Rouleau E, Solary E, De Baere T, Angevin E, Armand JP, Michiels S, Andre F, Deutsch E, Scoazec JY, Soria JC, Massard C. Human epidermal receptor family inhibitors in patients with ERBB3 mutated cancers: Entering the back door. Eur J Cancer. 2018 Mar;92:1-10. doi: 10.1016/j.ejca.2017.12.020. Epub 2018 Feb 3.

Reference Type DERIVED
PMID: 29413684 (View on PubMed)

Verlingue L, Malka D, Allorant A, Massard C, Ferte C, Lacroix L, Rouleau E, Auger N, Ngo M, Nicotra C, De Baere T, Tselikas L, Ba B, Michiels S, Scoazec JY, Boige V, Ducreux M, Soria JC, Hollebecque A. Precision medicine for patients with advanced biliary tract cancers: An effective strategy within the prospective MOSCATO-01 trial. Eur J Cancer. 2017 Dec;87:122-130. doi: 10.1016/j.ejca.2017.10.013. Epub 2017 Nov 14.

Reference Type DERIVED
PMID: 29145038 (View on PubMed)

Jovelet C, Ileana E, Le Deley MC, Motte N, Rosellini S, Romero A, Lefebvre C, Pedrero M, Pata-Merci N, Droin N, Deloger M, Massard C, Hollebecque A, Ferte C, Boichard A, Postel-Vinay S, Ngo-Camus M, De Baere T, Vielh P, Scoazec JY, Vassal G, Eggermont A, Andre F, Soria JC, Lacroix L. Circulating Cell-Free Tumor DNA Analysis of 50 Genes by Next-Generation Sequencing in the Prospective MOSCATO Trial. Clin Cancer Res. 2016 Jun 15;22(12):2960-8. doi: 10.1158/1078-0432.CCR-15-2470. Epub 2016 Jan 12.

Reference Type DERIVED
PMID: 26758560 (View on PubMed)

Other Identifiers

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2011/1755

Identifier Type: OTHER

Identifier Source: secondary_id

2011-A00841-40

Identifier Type: -

Identifier Source: org_study_id

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