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| ID | Type | Description | Link |
|---|---|---|---|
| 21-XTEAM-13 | Other Identifier | Christie NHS Foundation Trust |
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| Name | Class |
|---|---|
| The Christie NHS Foundation Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical cancer | Cervical cancer patients receiving standard of care radiotherapy |
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| Rectal cancer | Rectal cancer patients receiving standard of care radiotherapy |
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| Head and neck cancer | Head and neck cancer patients receiving standard of care radiotherapy |
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| nodal non-Hodgkin lymphoma | Patients with nodal NHL receiving standard of care radiotherapy |
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| cutaneous lymphoma | Patients with cutaneous lymphoma receiving standard of care radiotherapy |
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| cutaneous squamous cell carcinoma and basal cell carcinoma | Patients with cSCC and cBCC receiving standard of care radiotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy and blood sample collection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Within 6-7 weeks of starting radiotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Immunohistochemistry analysis of expression markers on tumour tissue | Immunohistochemistry (IHC) analysis of expression markers on tumours pre-radiotherapy and during/post radiotherapy | Within 6-7 weeks of starting radiotherapy |
| RNA evaluation of immune signatures |
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:
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Hospital clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lois Gardner | Contact | 01612008863 | lois.gardner@manchester.ac.uk | |
| Eleanor Cheadle | Contact | 01612008863 | eleanor.j.cheadle@manchester.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Timothy M Illidge | University of Manchester | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Pre-treatment and during/post-treatment tumour tissue, and matched blood samples
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RNA evaluation of immune signatures in tumour tissue and blood pre-radiotherapy and during/post radiotherapy |
| Within 6-7 weeks of starting radiotherapy |
| Analysis of peripheral blood mononuclear cells | Assessment of changes in immune phenotypic markers | 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 | Within 6-7 weeks of starting radiotherapy |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |