Investigating the Tumour Immune Response of Radiotherapy
ConditionCancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Manchester
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Hospital clinic
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biopsy and blood sample collection
Procedure/SurgeryA 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.
Treatment groups
120 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cervical cancer1 intervention
Group B: Rectal cancer1 intervention
Group C: Head and neck cancer1 intervention
Group D: nodal non-Hodgkin lymphoma1 intervention
Group E: cutaneous lymphoma1 intervention
Group F: cutaneous squamous cell carcinoma and basal cell carcinoma1 intervention
Trial outcomes
Primary outcomes
1
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 radiotherapy2
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 radiotherapyOther outcomes
1
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 radiotherapy2
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 radiotherapy3
Analysis of peripheral blood mononuclear cells
Assessment of changes in immune phenotypic markers
Time frame
Within 6-7 weeks of starting radiotherapy4
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 radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Manchester
Lead sponsor
The Christie NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov