Clinical trial NCT02458040: Clinical Benefit of Genetic Biomarkers for Guiding Treatment Decisions in Oncology Drugs
Official title: Clinical Benefit of Genetic Biomarkers for Guiding Treatment Decisions in Oncology Drugs
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Neoplasms
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2015-05-29
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a systematic review. No patient will be directly included in this study, but the investigators will include clinical trials.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 5 years
Other outcomes:
measure: Disease-Free Survival (DFS)
timeFrame: Up to 5 years
Locations:
city: Paris
country: France
facility: Hôpital Hôtel Dieu
Study officials:
References:
citation: 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.
citation: 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.