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Clinical Benefit of Genetic Biomarkers for Guiding Treatment Decisions in Oncology Drugs

NCT ID: NCT02458040

Last Updated: 2023-11-28

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-12-31

Brief Summary

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This study is a meta-epidemiological study which aim is to quantify the clinical benefit of the biomarker-based strategy compared to conventional strategy across all drugs with such a strategy.

Detailed Description

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Personalized medicine consist to differentially treat patients based on their individual characteristics (mainly genetics). It is of the most promising area of cancer research and cancer care. The label of more than 140 FDA- approved drugs mention a biomarker, the majority being indicated in oncology. However, it has also been suggested that the hopes of personalized medicine were not matched by evidence. Indeed, there is a threat that genetic biomarkers are used without evidence that this use translates in improved outcomes for patients, and the use of biomarkers is in need for thorough validation.

In a previous work the investigators showed that the mention of a pharmacogenomic biomarker in a drug label can have different meanings depending on the drug, and that oncology had higher proportion of required or recommended genetic testing compared to other therapeutic areas. Hence, the investigators will include only the drug-biomarker pairs with (i) required or recommended genetic testing, or (ii) with biomarker-based indication and (iii) with at least one indication in oncology.

Conditions

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Neoplasms

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Biomarker-positive patients

Drug selected in the study

Intervention Type DRUG

Biomarker-negative patients

Drug selected in the study

Intervention Type DRUG

All patients

Drug selected in the study

Intervention Type DRUG

Interventions

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Drug selected in the study

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* phase II or III randomized clinical trials
* including patients with one of the drug-biomarker-indication triplet studied
* evaluating treatment effect in biomarker-defined strata (either in biomarker-positive patients, in biomarker-negative patients or in both strata).
* reporting OS or PFS or DFS

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Hôtel Dieu

Paris, , France

Site Status

Countries

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France

References

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Vivot A, Boutron I, Ravaud P, Porcher R. Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs. Genet Med. 2015 Sep;17(9):733-8. doi: 10.1038/gim.2014.181. Epub 2014 Dec 18.

Reference Type BACKGROUND
PMID: 25521333 (View on PubMed)

Vivot A, Boutron I, Beraud-Chaulet G, Zeitoun JD, Ravaud P, Porcher R. Evidence for Treatment-by-Biomarker interaction for FDA-approved Oncology Drugs with Required Pharmacogenomic Biomarker Testing. Sci Rep. 2017 Jul 31;7(1):6882. doi: 10.1038/s41598-017-07358-7.

Reference Type RESULT
PMID: 28761069 (View on PubMed)

Other Identifiers

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PHRCK14-051

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BENEBIO01

Identifier Type: -

Identifier Source: org_study_id