Investigating the Tumour Immune Response of Radiotherapy
Recruiting
Observational Study
Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
120 (estimated)
Sponsor
University of Manchester · Other
Who this trial is looking for
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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.
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Eligibility Criteria
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…
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.
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