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Investigating the Tumour Immune Response of Radiotherapy

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Health checks and monitoring — no treatment given
Type of study: Observational (no treatment given)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Biopsy and blood sample collection (procedure)
How long the study runs: Study runs about 61 months (dates as stated)
About the drug or intervention: 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.
Patient visit burden: Not specified by the sponsor

Type of study: Observing health over time
Ages: 18 Years and over
Who: All
Number of participants: 120
Started: 2021-07-14
Last checked: 2025-06

Plain English Summary

What is this study?

• Testing a new treatment for cancer
• Clinical study - 120 participants
• This study aims to investigate immune changes which occur before and following standard radiotherapy in a range of tumour types

Who can take part?

• Ages 18 Years and over
• Diagnosed with cancer

Where?

• Manchester - Christie NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

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.

Cancer

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders
How fit you need to be: ECOG 0 or better

What the study is looking for

✓confirmed by a biopsy cancer, Stage I-IV, in one of the following: Cervical, rectal, nodal Non-Hodgkin lymphoma,...
✓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...
✓Age ≥ 18; no upper age limit.
✓Participant considered suitable for radiotherapy

Who cannot take part

✗Participants deemed unsuitable for a biopsy (during or following radiotherapy) in the opinion of the treating...
✗Participants who have received drug treatment within 28 days of starting radiotherapy.

See the full 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 Is This Study? (1 UK site)

Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting

Site contact (verified)

Catherine Trigwell01613066088 catherine.trigwell@manchester.ac.uk

How to Get in Touch

Lois Gardner

Sponsor contact

CONTACT

01612008863 lois.gardner@manchester.ac.uk

Eleanor Cheadle

Sponsor contact

CONTACT

01612008863 eleanor.j.cheadle@manchester.ac.uk

Data sourced from ClinicalTrials.gov · Last verified: 2025-06