Clinical trial · Observational
Clinical Benefit of Genetic Biomarkers for Guiding Treatment Decisions in Oncology Drugs
NCT02458040CI-TRIAL-00071760withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug selected in the study | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Biomarker-positive patients
- interventionNames
- Drug: Drug selected in the study
- label
- Biomarker-negative patients
- interventionNames
- Drug: Drug selected in the study
- label
- All patients
- interventionNames
- Drug: Drug selected in the study
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 5 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDVivot 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. PMID 25521333
- RESULTVivot 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. PMID 28761069