NCT05076500

Investigating the Tumour Immune Response of Radiotherapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: University of Manchester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
PROCEDURE	Biopsy and blood sample collection	A pre-treatment diagnostic biopsy sample plus 1 mandatory biopsy (during/post-radiotherapy \[irradiated site\]) will be collected from each participant. 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.

Timeline

• Start date: 2021-07-14
• Primary completion: 2026-07-14
• Completion: 2026-08-14
• First posted: 2021-10-13
• Last updated: 2025-06-11

Locations

1 site across 1 country: United Kingdom