Investigating the Tumour Immune Response of Radiotherapy

Recruiting

• Conditions: Cancer

• Registration Number: NCT05076500
• Lead Sponsor: University of Manchester

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.

Study Timeline

• Study Start: 2021-07-14
• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-11
• Primary Completion: 2026-07-14
• Study Completion: 2026-08-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of obtaining paired biopsy samples	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	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.

Trial Locations

Locations (1)

Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom