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Status unknownNCT01566019MOSCATO 02Updated Feb 17, 2020

Molecular Screening for Cancer Treatment Optimization

An interventional study of Tumoral biopsy in Metastatic Solid Tumors (Any Localization), sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Status unknown at 1 site in France. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2011, registered Mar 2012).
Phase
Not applicable
Study type
Interventional
Enrollment
2,150
Allocation
Not applicable
Ages
6 Months and older
Sex
All
01

Study summary

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.

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Conditions studied

  • Metastatic Solid Tumors (Any Localization)
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In context

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,150 participants (estimated)

Study arms

  • Experimental
    Patients with non curable metastatic cancer

    Procedure: Tumoral biopsy

Interventions

  • ProcedureTumoral biopsy

    Every enrolled patient undergoes tumoral biopsy

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What researchers measure

Primary outcomes

  1. Progression free survival (PFS) using a targeted treatment selected by molecular profiling compared to the PFS for the most recent regimen

    Progression according to RECIST criteria or clinical progression or death of any cause

    Time frame: From date of start of targeted treatment oriented by MOSCATO until the date of first progression or date of death from any cause, whichever came first, assessed up to 1 year

Secondary outcomes

  1. Number of patient who received a targeted treatment oriented by molecular profiling

    Number of patient who received a targeted treatment oriented by molecular profiling

    Time frame: From the start to the end of enrollment, up to 3 years

  2. Progression free Survival, Overall Survival and Response Rate

    Comparison of Progression Free Survival, Overall Survival and Response Rate between patients with targeted treatment and others enrolled patients.

    Time frame: Until progression, up to 1 year

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Study locations

1 of 1 sites recruiting
  • Institut Gustave Roussy
    Villejuif, Val De Marne 94805, France
    • Jean-Charles SORIA, MD, PhD · Contact · soria@igr.fr · +33 1 42 11 42 96
    • Christophe MASSARD, MD · Contact · christophe.massard@igr.fr · +33 04 42 11 52 10
    • Jean-Charles SORIA, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 35872509 ↗
  • 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. PubMed 29413684 ↗
  • 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. Erratum In: Eur J Cancer. 2018 Apr;93:156-157. doi: 10.1016/j.ejca.2018.01.077. PubMed 29145038 ↗
  • 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. PubMed 26758560 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01566019
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Responsible party
Sponsor
First posted
Mar 29, 2012
Start date
Oct 28, 2011
Primary completion
Oct 2020 (estimated)
Completion
Oct 2020 (estimated)
Last update
Feb 17, 2020

Study contacts

Jean-Charles SORIA, MD, PhD
principal investigator · Gustave Roussy, Cancer Campus, Grand Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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