An observational study in Cancer, sponsored by University of Manchester. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by University of Manchester · Observational
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.
The purpose of this prospective, non-CTIMP, translational study is to assess the feasibility of achieving paired biopsies for immune analysis in patients across six different cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma, cutaneous lymphoma and cutaneous squamous cell carcinoma/ basal cell carcinoma.
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.
University of Manchester is the lead sponsor of 194 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hospital clinic
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:
Exclusion Criteria:
Cervical cancer patients receiving standard of care radiotherapy
Procedure: Biopsy and blood sample collection
Rectal cancer patients receiving standard of care radiotherapy
Procedure: Biopsy and blood sample collection
Head and neck cancer patients receiving standard of care radiotherapy
Procedure: Biopsy and blood sample collection
Patients with nodal NHL receiving standard of care radiotherapy
Procedure: Biopsy and blood sample collection
Patients with cutaneous lymphoma receiving standard of care radiotherapy
Procedure: Biopsy and blood sample collection
Patients with cSCC and cBCC receiving standard of care radiotherapy
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.
Feasibility of obtaining paired biopsy samples
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.
Time frame: Within 6-7 weeks of starting radiotherapy
Collection of matched blood samples
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.
Time frame: Within 6-7 weeks of starting radiotherapy
Immunohistochemistry analysis of expression markers on tumour tissue
Immunohistochemistry (IHC) analysis of expression markers on tumours pre-radiotherapy and during/post radiotherapy
Time frame: Within 6-7 weeks of starting radiotherapy
RNA evaluation of immune signatures
RNA evaluation of immune signatures in tumour tissue and blood pre-radiotherapy and during/post radiotherapy
Time frame: Within 6-7 weeks of starting radiotherapy
Analysis of peripheral blood mononuclear cells
Assessment of changes in immune phenotypic markers
Time frame: Within 6-7 weeks of starting radiotherapy
Analysis of plasma proteins, cytokines and chemokines
Analysis of plasma proteins, cytokines and chemokines as biomarkers of immune response
Time frame: Within 6-7 weeks of starting radiotherapy
Plan to share: No
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University of Manchester