Overview
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.
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.
Eligibility
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.