Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer
NCT ID: NCT05029258
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2020-12-10
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Locally advanced cervical cancer patients treated with standard of care chemoradiation
Biopsy of tumour
Cervical tumour biopsy during treatment. This will be used for gene expression (RNA) analysis against a hypoxia associated gene signature.
MRI scans
Multiple magnetic resonance imaging (MRI) scans before and during treatment using oxygen enhanced (OE) / tissues oxygen level dependent (TOLD) sequence
Interventions
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Biopsy of tumour
Cervical tumour biopsy during treatment. This will be used for gene expression (RNA) analysis against a hypoxia associated gene signature.
MRI scans
Multiple magnetic resonance imaging (MRI) scans before and during treatment using oxygen enhanced (OE) / tissues oxygen level dependent (TOLD) sequence
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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The Christie NHS Foundation Trust
OTHER
University of Manchester
OTHER
Responsible Party
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Ananya Choudhury
Professor in Clinical Oncology, Principal Investigator
Locations
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The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Ananya Choudhury, Professor
Role: backup
Other Identifiers
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20_DOG01_181
Identifier Type: -
Identifier Source: org_study_id
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