NCT05076500 Investigating the Tumour Immune Response of Radiotherapy
| NCT ID | NCT05076500 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Manchester |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-07-14 |
| Primary Completion | 2026-07-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2021-07-14 with a primary completion date of 2026-07-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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.
Contact & Investigator
Timothy M Illidge
STUDY CHAIR
University of Manchester
Frequently Asked Questions
Who can join the NCT05076500 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05076500 currently recruiting?
Yes, NCT05076500 is actively recruiting participants. Contact the research team at lois.gardner@manchester.ac.uk for enrollment information.
Where is the NCT05076500 trial being conducted?
This trial is being conducted at Manchester, United Kingdom.
Who is sponsoring the NCT05076500 clinical trial?
NCT05076500 is sponsored by University of Manchester. The principal investigator is Timothy M Illidge at University of Manchester. The trial plans to enroll 120 participants.
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