Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer (Bio-CHECC)

May 9, 2026 updated by: Ananya Choudhury, University of Manchester
Patients with locally advanced cervical cancer (LACC) are primarily treated with radiotherapy +/- chemotherapy however 5-year survival rates are <60% with significant treatment toxicity. Hypoxia is a well-known radioresistant component of solid tumours such as cervical cancer and hypoxia modification therapies have demonstrated immense promise in treating such tumours. A major factor in determining a successful outcome with hypoxia modification is appropriate patient selection as it is hypoxic tumours that receive the most benefit from hypoxia modifying therapies. To date there is no validated hypoxia biomarker to stratify patients for therapy in cervical cancer in clinical use. This project offers a unique opportunity to examine both genetic and imaging biomarkers to optimise patient stratification when receiving curative radiotherapy for cervical cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Locations

  • United Kingdom
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Locally advanced cervical cancer patients

Description

Inclusion criteria:

  • Patients must have a histologically confirmed diagnosis of cervical cancer
  • Diagnostic/pre-treatment biopsy available
  • Patients must be suitable for standard radiotherapy and brachytherapy
  • Age greater than or equal to 18 years; no upper age limit
  • Performance status - ECOG 0-2 (Refer to appendix 1)
  • Women of childbearing age MUST have a negative pregnancy test prior to study entry and be using an adequate contraception method
  • Before participant registration, written informed consent must be given according to GCP and national regulations.

Exclusion criteria:

  • Participants deemed unsuitable for a biopsy (during or following radiotherapy) in the opinion of the treating oncologist.
  • Patients with cardiac pacemakers, cochlear implants, intraocular foreign bodies or any other MR contraindication
  • Patients with a hip replacement
  • Patients with a known history of allergic reaction to gadolinium-based contrast agent
  • Any contraindications to Hyoscine Butylbromide (Buscopan)
  • Any patient taking ACE inhibitors. These should be stopped/substituted or they are a contraindication.
  • Evidence of impaired renal function (eGFR <15 ml/min)
  • Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the study
  • Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the study
  • Any other serious uncontrolled medical conditions
  • Clinical evidence of metastatic disease
  • Any pregnant or lactating woman
  • Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
  • Any patient who is currently involved in, or who has recently been involved in other research

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Locally advanced cervical cancer patients treated with standard of care chemoradiation
Procedure: Biopsy of tumour
Cervical tumour biopsy during treatment. This will be used for gene expression (RNA) analysis against a hypoxia associated gene signature.
Diagnostic test: MRI scans
Multiple magnetic resonance imaging (MRI) scans before and during treatment using oxygen enhanced (OE) / tissues oxygen level dependent (TOLD) sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI derived hypoxia scores on 20 participants
Time Frame: 2 years
20 patients will undergo functional imaging (hypoxia MRI) at baseline. Following this, serial measurements will be taken on a weekly basis during the first 5 weeks of chemoradiation. The imaging and biopsy cohorts are the same.
2 years
Gene signature derived hypoxia scores on the same 20 participants.
Time Frame: 2 years
Investigators will collect paired biopsies at diagnosis and at brachytherapy in 20 locally advanced cervical cancer patients. The imaging and biopsy cohorts are the same.
2 years

Collaborators and Investigators

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

Sponsor

University of Manchester

Collaborators

The Christie NHS Foundation Trust

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)

December 10, 2020

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 31, 2021

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

  • 20_DOG01_181

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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