Investigating the Tumour Immune Response of Radiotherapy

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 five cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma and cutaneous lymphoma.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 1, 2023

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 five different cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma and cutaneous lymphoma. 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 participants per study arm, with the option to increase numbers in study arms that are recruiting well – a maximum of 100 patients in total will be recruited to the study.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Cervical cancer
    • Cervical cancer patients receiving standard of care radiotherapy
  • Rectal cancer
    • Rectal cancer patients receiving standard of care radiotherapy
  • Head and neck cancer
    • Head and neck cancer patients receiving standard of care radiotherapy
  • nodal non-Hodgkin lymphoma
    • Patients with nodal NHL receiving standard of care radiotherapy
  • cutaneous lymphoma
    • Patients with cutaneous lymphoma receiving standard of care radiotherapy

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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). – 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Manchester
  • Collaborator
    • The Christie NHS Foundation Trust
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tim Illidge, Professor of Targeted Therapy and Oncology – University of Manchester
  • Overall Official(s)
    • Timothy M Illidge, Study Chair, University of Manchester
  • Overall Contact(s)
    • Catherine Trigwell, 01613066088, catherine.trigwell@manchester.ac.uk

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