Investigating the Tumour Immune Response of Radiotherapy

NCT05076500 | Recruiting

• 2 other identifiers: NHS00168821-XTEAM-13
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• Feasibility of obtaining paired biopsy samples

  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.

  Within 6-7 weeks of starting radiotherapy

• Collection of matched blood samples

  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.

  Within 6-7 weeks of starting radiotherapy

Other Outcomes (4)

• Immunohistochemistry analysis of expression markers on tumour tissue

  Within 6-7 weeks of starting radiotherapy

• RNA evaluation of immune signatures

  Within 6-7 weeks of starting radiotherapy

• Analysis of peripheral blood mononuclear cells

  Within 6-7 weeks of starting radiotherapy

Study Arms (6)

Cervical cancer

Cervical cancer patients receiving standard of care radiotherapy

Procedure: Biopsy and blood sample collection

Rectal cancer

Rectal cancer patients receiving standard of care radiotherapy

Procedure: Biopsy and blood sample collection

Head and neck cancer

Head and neck cancer patients receiving standard of care radiotherapy

Procedure: Biopsy and blood sample collection

nodal non-Hodgkin lymphoma

Patients with nodal NHL receiving standard of care radiotherapy

Procedure: Biopsy and blood sample collection

cutaneous lymphoma

Patients with cutaneous lymphoma receiving standard of care radiotherapy

Procedure: Biopsy and blood sample collection

cutaneous squamous cell carcinoma and basal cell carcinoma

Patients with cSCC and cBCC receiving standard of care radiotherapy

Procedure: Biopsy and blood sample collection

Interventions

Biopsy and blood sample collection PROCEDURE

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.

Cervical cancer; Head and neck cancer; Rectal cancer; cutaneous lymphoma; cutaneous squamous cell carcinoma and basal cell carcinoma; nodal non-Hodgkin lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital clinic

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead
• The Christie NHS Foundation Trust: collaborator

Study Sites (1)

Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Pre-treatment and during/post-treatment tumour tissue, and matched blood samples

MeSH Terms

Conditions

Neoplasms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Timothy M Illidge

  University of Manchester

  STUDY CHAIR

Central Study Contacts

Lois Gardner

CONTACT

01612008863; lois.gardner@manchester.ac.uk

Eleanor Cheadle

CONTACT

01612008863; eleanor.j.cheadle@manchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Targeted Therapy and Oncology

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 13, 2021
• Study Start: July 14, 2021
• Primary Completion (Estimated): July 14, 2026
• Study Completion (Estimated): August 14, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)