Selecting Hypoxic Tumours for Treatment Modification (SELECT)

May 9, 2026 updated by: Ananya Choudhury, University of Manchester
Approximately 50% of cancer patients with solid tumours will be treated with radiotherapy. A significant proportion (>25%) of patients have hypoxic tumours which respond poorly to radiotherapy. Hypoxic tumours have a poor prognosis. This can be improved with treatment intensification. Treatment intensification can be modification with CON (breathing O2-enriched air + oral administration of nicotinamide), chemoradiosensitisation, radiation dose-escalation or additional systemic treatments, significantly improving response of the tumours to radiotherapy. However, there are currently no clinically approved biomarkers to identify hypoxic tumours. Our group has developed and validated gene-expression signature-based biomarkers that identify patients with hypoxic bladder, head and neck , prostate, sarcoma and lung cancers. The bladder cancer gene-expression hypoxia signature has been shown to predict benefit from hypoxia modification using RNA from archived tumour tissue. The main purpose of this study is to demonstrate in at least two cancer types that the hypoxia biomarker predicts benefit from hypoxia modification in real-time.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Research Question: Can hypoxia biomarkers personalised treatment improve cancer outcomes?

Cancers that are hypoxic (have a high percentage of regions of low local O2 concentration) are refractory to radiotherapy but benefit from hypoxia modification. However, there are no biomarkers to identify patients with hypoxic tumours. The gold standard for determining tissue O2 concentration is the O2-electrode which takes measurements at several sites within the tumour. However, this necessitates insertion of a needle into multiple regions of the tumour so is invasive and provides only a localised hypoxia status. Other hypoxia biomarkers that identify hypoxia have been derived from cell surface protein expression, gene expression or imaging outputs. Proteins expressed on the tumour cell surface of hypoxic cells include CA9 and glut1 but the expression of these proteins is not specific to hypoxia and is highly heterogeneous within tumours. Whilst expression of HIF1 by hypoxic tumours has been shown not to predict benefit from hypoxia-modification. Gene signatures are a set of genes in which the collective changed expression has been validated to demonstrate diagnosis, prognosis or predict therapeutic response. Gene expression is consistently altered across tumours with high hypoxic fractions meaning that they are robust indicators of hypoxia status.

Using RNA extracted from archived material (Formalin fixed paraffin embedded tumour tissue) our gene-expression signature-based biomarkers for bladder, head and neck, prostate, sarcoma, cervical and lung cancers have been validated by demonstrated prognosis in each of the cancer groups. Further the 24 gene bladder cancer hypoxia signature has been shown to be predictive of benefit from hypoxia modification for patients with hypoxic tumours receiving radiotherapy. A recent review of predictive biomarkers in cancer treatment has shown that this is the only predictive biomarker for hypoxia-modification during radiotherapy.

Hypoxic regions in tumours can also be identified using MRI techniques including O2-senstive MRI (OE-MRI) and Intravoxel incoherent motion imaging. Combining imaging with gene expression data results in more accurate assessment of hypoxic status and identify tumour subtype which further contributes to personalised clinical decisions. MRI-based techniques also facilitate localized personalization approaches, e.g., for hypoxia-directed focal radiotherapy dose escalation.

Primary Question/Objective:

Short objective; to establish trials to test if personalised use of established hypoxia-targeted treatments with radiotherapy improves survival and work with the North West Genomics Hub to progress implementing our tissue hypoxia test for delivery across the NHS.

Medium objective; integrate MR imaging in the workflow for measuring hypoxia in at least two tumour sites.

Secondary Question/Objective:

  • Integrate radiological parameters with the hypoxia biomarker for personalising treatment.
  • Can blood-based biomarkers be early response biomarkers.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient recruitment will be via the disease site clinics .

Description

Inclusion Criteria:

This will be tumour site dependent.

Bladder:

  • Older than age 18 years.
  • Patients having radiotherapy at the Christie NHS Foundation Trust suitable for imaging on an MRI scanner.
  • Able to give informed consent.

Cervix:

  • Older than age 18 years.
  • Patients having radiotherapy at the Christie NHS Foundation Trust suitable for imaging on an MRI scanner.
  • Able to give informed consent.

Prostate:

  • Older than age 18 years.
  • Patients having radiotherapy at the Christie NHS Foundation Trust suitable for imaging on an MRI scanner.
  • Able to give informed consent.

Exclusion Criteria:

This will be tumour site dependent

Bladder:

  • Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.
  • Unable to tolerate MRI scans.
  • Pregnancy.

Cervix:

  • Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.
  • Unable to tolerate MRI scans.
  • Pregnancy.

Prostate:

  • Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.
  • Unable to tolerate MRI scans

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Bladder
Patients diagnosed with bladder cancer
Prostate
Patients diagnosed with prostate cancer
Cervix
Patients diagnosed with cervical cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary
Time Frame: Through to study completion, until May 2028
To have collected the FFPE tumour blocks and generate the gene signature.
Through to study completion, until May 2028

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome Measure
Time Frame: end of the study in May 2028

To have collected a total of at least 4 different patient blood samples which have corresponding MRI scans from each participant in this study undergoing imaging or treatment.

To have developed and optimised MR sequences, which can be used across Manchester and Lancashire in at least two tumour sites.
end of the study in May 2028

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Investigators

  • Principal Investigator: Ananya Choudhury, Professor, University of Manchester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2024

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 9, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24_DOG13_38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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