Investigating immune changes in cancer patients undergoing radiotherapy
Investigating the Tumour Immune Response of Radiotherapy
This study looks at how radiotherapy changes the immune system in cancer patients by collecting blood and tissue samples before and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manchester Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Manchester) |
| Trial ID | NCT05076500 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the immune response in patients with various types of cancer before and after they receive standard radiotherapy. Participants will provide tissue and blood samples for analysis, focusing on six cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma, cutaneous lymphoma, and cutaneous squamous cell carcinoma/basal cell carcinoma. The study will assess the feasibility of obtaining paired biopsies for immune analysis, with a target recruitment of up to 120 patients. The goal is to better understand how radiotherapy affects the immune system in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed Stage I-IV cancer in one of the specified types who are suitable for radiotherapy.
Not a fit: Patients who are not suitable for biopsy or those with conditions that prevent them from undergoing radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of immune responses to radiotherapy, potentially leading to improved treatment strategies for cancer patients.
How similar studies have performed: While similar studies investigating immune responses to cancer treatments exist, this specific approach focusing on paired biopsies in multiple cancer types is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Manchester
- Christie NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Lois Gardner
- Email: lois.gardner@manchester.ac.uk
- Phone: 01612008863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.