NCT02458040

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 28, 2023

Status Verified

May 1, 2015

Enrollment Period

1.6 years

First QC Date

May 19, 2015

Last Update Submit

November 22, 2023

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    Up to 5 years

Secondary Outcomes (1)

  • Progression-Free Survival (PFS)

    Up to 5 years

Other Outcomes (1)

  • Disease-Free Survival (DFS)

    Up to 5 years

Study Arms (3)

Biomarker-positive patients

Drug: Drug selected in the study

Biomarker-negative patients

Drug: Drug selected in the study

All patients

Drug: Drug selected in the study

Interventions

Drug selected in the studyDRUG
All patientsBiomarker-negative patientsBiomarker-positive patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Hôtel Dieu

Paris, France

Location

Related Publications (2)

  • 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.

    PMID: 25521333BACKGROUND

  • 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.

    PMID: 28761069RESULT

MeSH Terms

Conditions

Neoplasms
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 29, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 28, 2023

Record last verified: 2015-05

Locations

FR(1)