The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX, United Kingdom
NCT Number: NCT05029258
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Female
Observational
Manchester, Greater Manchester, M20 4BX, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cervical tumour biopsy during treatment. This will be used for gene expression (RNA) analysis against a hypoxia associated gene signature.
Multiple magnetic resonance imaging (MRI) scans before and during treatment using oxygen enhanced (OE) / tissues oxygen level dependent (TOLD) sequence
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.
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.
University of Manchester
Other
Acronym: Bio-CHECC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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