TIMM-RAD: Investigating the Tumour Immune Response of Radiotherapy

Sponsor
University of Manchester (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076500
Collaborator
The Christie NHS Foundation Trust (Other)
100
Enrollment
1
Location
34.6
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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 five cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma and cutaneous lymphoma.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Biopsy and blood sample collection

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 five different cancer types: cervical, rectal, Head and Neck cancer, nodal non-Hodgkin lymphoma and cutaneous lymphoma.

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 participants per study arm, with the option to increase numbers in study arms that are recruiting well - a maximum of 100 patients in total will be recruited to the study.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Investigating the Tumour Immune Response of Radiotherapy
Actual Study Start Date :
Jul 14, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

ArmIntervention/Treatment
Cervical cancer

Cervical cancer patients receiving standard of care radiotherapy

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.

Rectal cancer

Rectal cancer patients receiving standard of care radiotherapy

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.

Head and neck cancer

Head and neck cancer patients receiving standard of care radiotherapy

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.

nodal non-Hodgkin lymphoma

Patients with nodal NHL receiving standard of care radiotherapy

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.

cutaneous lymphoma

Patients with cutaneous lymphoma receiving standard of care radiotherapy

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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of obtaining paired biopsy samples [Within 6-7 weeks of starting radiotherapy]

    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.

  2. Collection of matched blood samples [Within 6-7 weeks of starting radiotherapy]

    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.

Other Outcome Measures

  1. Immunohistochemistry analysis of expression markers on tumour tissue [Within 6-7 weeks of starting radiotherapy]

    Immunohistochemistry (IHC) analysis of expression markers on tumours pre-radiotherapy and during/post radiotherapy

  2. RNA evaluation of immune signatures [Within 6-7 weeks of starting radiotherapy]

    RNA evaluation of immune signatures in tumour tissue and blood pre-radiotherapy and during/post radiotherapy

  3. Analysis of peripheral blood mononuclear cells [Within 6-7 weeks of starting radiotherapy]

    Assessment of changes in immune phenotypic markers

  4. Analysis of plasma proteins, cytokines and chemokines [Within 6-7 weeks of starting radiotherapy]

    Analysis of plasma proteins, cytokines and chemokines as biomarkers of immune response

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

  • 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Christie NHS Foundation TrustManchesterUnited KingdomM20 4BX

Sponsors and Collaborators

  • University of Manchester
  • The Christie NHS Foundation Trust

Investigators

  • Study Chair: Timothy M Illidge, University of Manchester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tim Illidge, Professor of Targeted Therapy and Oncology, University of Manchester
ClinicalTrials.gov Identifier:
NCT05076500
Other Study ID Numbers:
  • NHS001688
  • 21-XTEAM-13
First Posted:
Oct 13, 2021
Last Update Posted:
Oct 13, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 13, 2021