Investigating the Tumour Immune Response of Radiotherapy
NCT ID: NCT05076500
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2021-07-14
2026-08-14
Brief Summary
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Detailed Description
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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 10-20 participants per study arm, with the option to increase numbers in study arms that are recruiting well - a maximum of 120 patients in total will be recruited to the study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cervical cancer
Cervical cancer patients receiving standard of care radiotherapy
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.
Rectal cancer
Rectal cancer patients receiving standard of care radiotherapy
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.
Head and neck cancer
Head and neck cancer patients receiving standard of care radiotherapy
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.
nodal non-Hodgkin lymphoma
Patients with nodal NHL receiving standard of care radiotherapy
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.
cutaneous lymphoma
Patients with cutaneous lymphoma receiving standard of care radiotherapy
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.
cutaneous squamous cell carcinoma and basal cell carcinoma
Patients with cSCC and cBCC receiving standard of care radiotherapy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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The Christie NHS Foundation Trust
OTHER
University of Manchester
OTHER
Responsible Party
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Tim Illidge
Professor of Targeted Therapy and Oncology
Principal Investigators
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Timothy M Illidge
Role: STUDY_CHAIR
University of Manchester
Locations
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Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21-XTEAM-13
Identifier Type: OTHER
Identifier Source: secondary_id
NHS001688
Identifier Type: -
Identifier Source: org_study_id
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