Investigating the Tumour Immune Response of Radiotherapy

Cancer Clinical Trial

— TIMM-RAD  

Official title:

Investigating the Tumour Immune Response of Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05076500
• Other study ID #: NHS001688
• Secondary ID: 21-XTEAM-13
• Status: Recruiting
• Start date: July 14, 2021
• Est. completion date: June 14, 2025

Study information

• Verified date: November 2023
• Source: University of Manchester
• Contact: Lois Gardner
• Phone: 01612008863
• Email: lois.gardner[@]manchester.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 14, 2025
• Est. primary completion date: July 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• Biopsy and blood sample collection
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.

Locations

Country	Name	City	State
United Kingdom	Christie NHS Foundation Trust	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University of Manchester	The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	RNA evaluation of immune signatures	RNA evaluation of immune signatures in tumour tissue and blood pre-radiotherapy and during/post radiotherapy	Within 6-7 weeks of starting radiotherapy
Other	Analysis of peripheral blood mononuclear cells	Assessment of changes in immune phenotypic markers	Within 6-7 weeks of starting radiotherapy
Other	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
Primary	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
Primary	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