Investigating immune changes in cancer patients undergoing radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the immune response in patients with various types of cancer before and after they receive standard radiotherapy. Participants will provide tissue and blood samples for analysis, focusing on six cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma, cutaneous lymphoma, and cutaneous squamous cell carcinoma/basal cell carcinoma. The study will assess the feasibility of obtaining paired biopsies for immune analysis, with a target recruitment of up to 120 patients. The goal is to better understand how radiotherapy affects the immune system in these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Christie NHS Foundation Trust
  Manchester, United Kingdom Recruiting

Study contacts

• Study coordinator: Lois Gardner
• Email: lois.gardner@manchester.ac.uk
• Phone: 01612008863

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.