CancerTIMM-RADNCT05076500
Investigating the Tumour Immune Response of Radiotherapy
An observational study of Cancer, run by University of Manchester at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Biopsy and blood sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jul 2021to 14 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital clinic
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Christie NHS Foundation Trust
Manchester, M20 4BX
Catherine Trigwell, 01613066088, catherine.trigwell@manchester.ac.uk
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Biopsy and blood sample collection
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy and blood sample collectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cervical cancer | Cervical cancer patients receiving standard of care radiotherapy Receives: Procedure: Biopsy and blood sample collection | |
| Rectal cancer | Rectal cancer patients receiving standard of care radiotherapy Receives: Procedure: Biopsy and blood sample collection | |
| Head and neck cancer | Head and neck cancer patients receiving standard of care radiotherapy Receives: Procedure: Biopsy and blood sample collection | |
| nodal non-Hodgkin lymphoma | Patients with nodal NHL receiving standard of care radiotherapy Receives: Procedure: Biopsy and blood sample collection | |
| cutaneous lymphoma | Patients with cutaneous lymphoma receiving standard of care radiotherapy Receives: Procedure: Biopsy and blood sample collection | |
| cutaneous squamous cell carcinoma and basal cell carcinoma | Patients with cSCC and cBCC receiving standard of care radiotherapy Receives: Procedure: Biopsy and blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6-7 weeks of starting radiotherapy
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.
Measured: Within 6-7 weeks of starting radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start14 Jul 2021
- Primary completion14 Jul 2026 (estimated)
- Study completion14 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- The Christie NHS Foundation Trust
- Responsible party
- Principal investigator, Tim Illidge, University of Manchester
- Investigators
- Timothy M Illidge, Study chair, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076500
- Sponsor's protocol ID
- NHS001688
- Other IDs
- 21-XTEAM-13
- Acronym
- TIMM-RAD
- Status last verified
- Jun 2025
- First submitted
- 30 Sep 2021
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Tumour Immune Response of Radiotherapy
- ClinicalTrials.gov ID
- NCT05076500
- Acronym / sponsor ID
- TIMM-RAD / NHS001688
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- The Christie NHS Foundation Trust
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 14 Jul 2026 (estimated)
- Study completion
- 14 Aug 2026 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cervical cancer | – | Procedure: Biopsy and blood sample collectionCervical cancer patients receiving standard of care radiotherapy |
| Rectal cancer | – | Procedure: Biopsy and blood sample collectionRectal cancer patients receiving standard of care radiotherapy |
| Head and neck cancer | – | Procedure: Biopsy and blood sample collectionHead and neck cancer patients receiving standard of care radiotherapy |
| nodal non-Hodgkin lymphoma | – | Procedure: Biopsy and blood sample collectionPatients with nodal NHL receiving standard of care radiotherapy |
| cutaneous lymphoma | – | Procedure: Biopsy and blood sample collectionPatients with cutaneous lymphoma receiving standard of care radiotherapy |
| cutaneous squamous cell carcinoma and basal cell carcinoma | – | Procedure: Biopsy and blood sample collectionPatients with cSCC and cBCC receiving standard of care radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital clinic
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy and blood sample collectionA 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. | Procedure or surgery | Cervical cancer, Head and neck cancer, Rectal cancer, cutaneous lymphoma, cutaneous squamous cell carcinoma and basal cell carcinoma, nodal non-Hodgkin lymphoma |
Primary outcome
Feasibility of obtaining paired biopsy samples
Time frame: 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.
Collection of matched blood samples
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy M Illidge study chair
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lois Gardner (01612008863, lois.gardner@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of obtaining paired biopsy samples (time frame: Within 6-7 weeks of starting radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.