Investigating the Tumour Immune Response of Radiotherapy (TIMM-RAD)

University of Manchester

Status: Enrolling

Conditions: Cancer

Treatments: Procedure: Biopsy and blood sample collection

Study type: Observational

Funder types: Other

Identifiers

NCT05076500

21-XTEAM-13 (Other Identifier)

NHS001688

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 6 patient groups

Cervical cancer

Description:

Cervical cancer patients receiving standard of care radiotherapy

Treatment:

Procedure: Biopsy and blood sample collection

Rectal cancer

Description:

Rectal cancer patients receiving standard of care radiotherapy

Treatment:

Procedure: Biopsy and blood sample collection

Head and neck cancer

Description:

Head and neck cancer patients receiving standard of care radiotherapy

Treatment:

Procedure: Biopsy and blood sample collection

nodal non-Hodgkin lymphoma

Description:

Patients with nodal NHL receiving standard of care radiotherapy

Treatment:

Procedure: Biopsy and blood sample collection

cutaneous lymphoma

Description:

Patients with cutaneous lymphoma receiving standard of care radiotherapy

Treatment:

Procedure: Biopsy and blood sample collection

cutaneous squamous cell carcinoma and basal cell carcinoma

Description:

Patients with cSCC and cBCC receiving standard of care radiotherapy

Treatment:

Procedure: Biopsy and blood sample collection