Use of HPV-301 REVEAL 1,HPV-303 REVEAL 2, RRP-001 samples for HPV qPCR
Research type
Research Study
Full title
Non interventional, retrospective feasibility and development studies for the testing of DNA extracted from FFPE tissue samples derived from patients that participated in one of the following clinical trials REVEAL 1, REVEAL 2 or RRP-001. The results from this study will be used to determine if the targets of interest can be detected using a qPCR kit in development.
IRAS ID
325610
Contact name
Beth Davies
Contact email
Sponsor organisation
QIAGEN
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 6 months, 3 days
Research summary
INOVIO have partnered with QIAGEN to further develop the therascreen HPV Panel RGQ PCR kit to be used for patient enrolment in a possible phase 3 pivotal trial. The HPV Panel kit is being developed as an investigation use only device to identify HPV 6 and/or HPV 11 DNA in FFPE tissue from recurrent respiratory papillomatosis patients.
Samples will be provided by a pharmaceutical partner, INOVIO, from patients that have participated in either HPV-301 REVEAL 1, HPV-303 REVEAL2 or RRP-001 clinical trials and their samples have been stored for additional research purposes. Participants will have consented to the use of tissue samples being used for development laboratory assays.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0057
Date of REC Opinion
6 Mar 2023
REC opinion
Favourable Opinion