Exploratory investigation of bioPET for risk adapted management of HL
Research type
Research Study
Full title
Exploratory investigation of integrating gene signatures and interim PET imaging data for prognostic assessment and risk adapted management of early stage Hodgkin lymphoma (HL)
IRAS ID
180252
Contact name
Kim Linton
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Early stage Hodgkin Lymphoma (HL) has a very good prognosis following treatment with standard combination chemotherapy and radiotherapy. However radiotherapy may not be required in patients cured with chemotherapy alone, and is associated with an increased risk of second cancers and cardiovascular disease both of which undermine long term survival. Accurate identification of patients who do/do not require radiotherapy after chemotherapy is therefore highly desirable. The randomised phase 3 RAPID clinical trial demonstrated that interim FDG-PET imaging is an excellent prognostic biomarker in patients with early stage HL, and capable of guiding therapy escalation and de-escalation decisions (CI Radford, NEJM 2016). However, there is still a higher rate of relapse in patients with a negative interim PET (i.e. no active disease left) who are randomised to receive no radiotherapy. Greater risk precision is therefore needed. Gene expression patterns are known to be powerful determinants of tumour behaviour and prognosis in HL. We hypothesise that combining gene expression data with interim PET data will provide more accurate prognostic information to allow for greater precision and risk adapted therapy decisions. The current study will measure gene expression signatures for 58 genes in up to 455 patients enrolled on the RAPID trial. We will use a commercial gene expression profiling approach (Quantigene Plex) and previously collected tumour tissue biopsies. Results will be correlated with existing clinical outcome and PET imaging data held at the UCL clinical trials office. Results will be used to develop an integrated biological and PET imaging prognostic biomarker (bioPET).
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0137
Date of REC Opinion
2 May 2018
REC opinion
Favourable Opinion