use of assay to identify HER2 mutation-positive patients
Research type
Research Study
Full title
Protocol for the Use of the HER-Seq Assay in a blood-based screening study to identify HER2 mutation-positive patients for enrollment into clinical research studies of an investigational small-molecule pan-erythroblastic leukemia viral oncogene homolog (ERBB) tyrosine kinase inhibitor (TKI)
IRAS ID
259235
Contact name
Jude ODonnell
Contact email
Sponsor organisation
Almac Diagnostics
Clinicaltrials.gov Identifier
107931, US FDA IND
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is an observational genomic screening study. Samples obtained previously from Patients with histologically-confirmed metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) for treatment or follow-up of their disease will be screened at 3 to 6 months intervals, coincident with the scheduled patient visits during the pharmaceutical sponsors trial, to detect mutations in the HER2 gene from circulating tumor DNA from plasma. Blood samples will be collected from eligible patients during the pharmaceutical sponsors trial and the DNA sequenced using targeted next generation sequencing (NGS). A certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. For those patients identified as having an eligible activating HER2 mutation, further information on available study treatment protocols will be provided in the molecular report. Patients enrolled in participating institutions who are identified with these HER2 mutations by this screening protocol will have future potential access to specific treatment protocols.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
19/WM/0103
Date of REC Opinion
5 Mar 2019
REC opinion
Favourable Opinion