Investigating the Tumour Immune Response of Radiotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of Manchester
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Feasibility of obtaining paired biopsy samples
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
This study aims to investigate immune changes which occur before and following standard radiotherapy in a range of tumour types. We will collect tissue and blood samples before and after radiation treatment from participants across six cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma, cutaneous lymphoma and cutaneous squamous cell carcinoma/ basal cell carcinoma.
Detailed Description
The purpose of this prospective, non-CTIMP, translational study is to assess the feasibility of achieving paired biopsies for immune analysis in patients across six different cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma, cutaneous lymphoma and cutaneous squamous cell carcinoma/ basal cell carcinoma. All participants will have a minimum of 1 mandatory biopsy (during/post-radiotherapy \[irradiated site\]) and the potential to have a pre-treatment biopsy if the archival biopsy does not meet the suitability criteria. Matched blood samples will be collected from participants at baseline, during/post-radiotherapy, and if radiotherapy continues after the on-treatment biopsy is taken, an additional end of treatment blood sample will be collected. We aim to recruit 10-20 participants per study arm, with the option to increase numbers in study arms that are recruiting well - a maximum of 120 patients in total will be recruited to the study.
Investigators
Tim Illidge
Professor of Targeted Therapy and Oncology
University of Manchester
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed cancer, Stage I-IV, in one of the following: Cervical, rectal, nodal Non-Hodgkin lymphoma, cutaneous lymphoma, Head \& neck cancer
- •Diagnostic/pre-treatment biopsy confirmed suitable for translational research \*
- •Performance status - ECOG 0-2 (Refer to appendix 1), ECOG 3 allowed for arm F (unrelated to underlying cancer) as this group of patients often have ECOG 3 due to age and comorbidities.
- •Age ≥ 18; no upper age limit.
- •Participant considered suitable for radiotherapy
- •Before participant registration, written informed consent must be given according to GCP and national regulations.
- •\*Pre-treatment biopsy must be from the gross tumour volume within the planned radiation field and must also:
- •Have been formalin fixed for \>12h and \<72h
- •Have tumour tissue and morphology confirmed by H\&E staining
- •Contain sufficient tumour cells (approximately 100)
Exclusion Criteria
- •Participants deemed unsuitable for a biopsy (during or following radiotherapy) in the opinion of the treating oncologist.
- •Participants who have received chemotherapy within 28 days of starting radiotherapy.
- •Participants with intercurrent or past history of hepatitis B, C or human immunodeficiency virus infection if known. A negative test result for hepatitis B, C and HIV infection is required prior to inclusion in the study.
Outcomes
Primary Outcomes
Feasibility of obtaining paired biopsy samples
Time Frame: Within 6-7 weeks of starting radiotherapy
To assess the feasibility of obtaining tumour samples pre-radiotherapy (diagnostic or fresh) and a second biopsy during or immediately after radiotherapy, or a surgical sample, from patients undergoing standard of care RT.
Collection of matched blood samples
Time Frame: Within 6-7 weeks of starting radiotherapy
To obtain additional matched blood samples pre-radiotherapy, during or post-radiotherapy, and at the end of radiotherapy for assessment of immune status of peripheral blood in comparison to the intratumoural microenvironment.