Bio-CHECC
Research type
Research Study
Full title
Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer
IRAS ID
279928
Contact name
Peter Hoskin
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
A28707, ARCTIC CAT Award
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
Hypoxia (low oxygen level) within solid tumours is related to poorer outcomes for patients. These tumours also demonstrate a resistance to radiotherapy, and higher doses are required to reach the same level of disease control. This makes therapy challenging and is a particular problem in cervical cancer which is primarily treated with radiation.
A possible way to increase the effects of radiotherapy on the tumour is to use hypoxia modifying medications. We know these medications show the greatest benefit in the most hypoxic tumours, however there is no proven strategy to identify these patients. Biological markers (biomarkers) specific to hypoxia can be used to inform clinicians about the various pathways in the body. Two candidate biomarkers with the greatest promise are derived from gene testing and magnetic resonance imaging (MRI) methods. The study will combine data from these two methods and aims to guide future research in this area.
Patients enrolled in the study will continue with the standard of care therapy as prescribed by the clinician responsible for their treatment. This is a basic science study that will observe the impact of radiotherapy on the genetic and MRI derived biomarkers during treatment.
Patients will be enrolled in the study for 3 months during which they will undergo serial imaging and two biopsy samples alongside their treatment. The study is recruiting patients older than the age of 18, diagnosed with cervical cancer and have not started therapy, and are not pregnant. An additional biopsy and MRI will be offered at 12 months if deemed necessary by the lead clinician. All treatment and research will be conducted on The Christie Hospital NHS Trust site.
REC name
North West - Preston Research Ethics Committee
REC reference
20/NW/0377
Date of REC Opinion
20 Oct 2020
REC opinion
Further Information Favourable Opinion