Clinical trial NCT05076500: Investigating the Tumour Immune Response of Radiotherapy
Official title: Investigating the Tumour Immune Response of Radiotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: The Christie NHS Foundation Trust
First posted: 2021-10-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital clinic

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Feasibility of obtaining paired biopsy samples
timeFrame: Within 6-7 weeks of starting radiotherapy
measure: Collection of matched blood samples
timeFrame: Within 6-7 weeks of starting radiotherapy
Secondary outcomes:
Other outcomes:
measure: Immunohistochemistry analysis of expression markers on tumour tissue
timeFrame: Within 6-7 weeks of starting radiotherapy
measure: RNA evaluation of immune signatures
timeFrame: Within 6-7 weeks of starting radiotherapy
measure: Analysis of peripheral blood mononuclear cells
timeFrame: Within 6-7 weeks of starting radiotherapy
measure: Analysis of plasma proteins, cytokines and chemokines
timeFrame: Within 6-7 weeks of starting radiotherapy
Locations:
city: Manchester
country: United Kingdom
facility: Christie NHS Foundation Trust
Study officials:
affiliation: University of Manchester
name: Timothy M Illidge
role: STUDY_CHAIR
References: