NCT05029258

Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University of Manchester · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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. 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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-12-10
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2021-08-31
• Last updated: 2025-01-20

Locations

1 site across 1 country: United Kingdom