Cervical CancerBio-CHECCNCT05029258
Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer
An observational study of Cervical Cancer, run by University of Manchester at 1 site in United Kingdom.
Trial summary
Patients with locally advanced cervical cancer (LACC) are primarily treated with radiotherapy +/- chemotherapy however 5-year survival rates are <60% with significant treatment toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Biopsy of tumour and MRI scans
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Dec 2020to 31 Oct 2027
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Locally advanced cervical cancer patients
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX
About this study
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.
- Conditions
- Cervical Cancer
- Being tested
- Biopsy of tumour, MRI scans
- Keywords
- Hypoxia, Radiotherapy, Gene expression, Imaging
- Medical subject headings
- Uterine Cervical Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy of tumourProcedure or surgery
Cervical tumour biopsy during treatment. This will be used for gene expression (RNA) analysis against a hypoxia associated gene signature.
MRI scansDiagnostic test
Multiple magnetic resonance imaging (MRI) scans before and during treatment using oxygen enhanced (OE) / tissues oxygen level dependent (TOLD) sequence
| Study group | Role | What they receive |
|---|---|---|
| Locally advanced cervical cancer patients treated with standard of care chemoradiation | Not described Receives: Procedure: Biopsy of tumour; Diagnostic Test: MRI scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI derived hypoxia scores on 20 participants
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.
Measured: 2 years
Gene signature derived hypoxia scores on the same 20 participants.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start10 Dec 2020
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- 30 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, Ananya Choudhury, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029258
- Sponsor's protocol ID
- 20_DOG01_181
- Acronym
- Bio-CHECC
- Status last verified
- May 2026
- First submitted
- 19 Aug 2021
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer
- ClinicalTrials.gov ID
- NCT05029258
- Acronym / sponsor ID
- Bio-CHECC / 20_DOG01_181
- Conditions
- Cervical Cancer
- Keywords
- Hypoxia, Radiotherapy, Gene expression, Imaging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- The Christie NHS Foundation Trust
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 31 Aug 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locally advanced cervical cancer patients treated with standard of care chemoradiation | – | Procedure: Biopsy of tumour, Diagnostic Test: MRI scans |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced cervical cancer patients
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (14 listed)
- 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)
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 of tumourCervical tumour biopsy during treatment. This will be used for gene expression (RNA) analysis against a hypoxia associated gene signature. | Procedure or surgery | Locally advanced cervical cancer patients treated with standard of care chemoradiation |
| MRI scansMultiple magnetic resonance imaging (MRI) scans before and during treatment using oxygen enhanced (OE) / tissues oxygen level dependent (TOLD) sequence | Diagnostic test | Locally advanced cervical cancer patients treated with standard of care chemoradiation |
Primary outcome
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.
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.
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 12 May 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Cervical 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 7 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI derived hypoxia scores on 20 participants (time frame: 2 years). 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 12 May 2026.