Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer

Recruiting

• Conditions: Cervical Cancer
• Interventions: Procedure: Biopsy of tumour; Diagnostic Test: MRI scans

• Registration Number: NCT05029258
• Lead Sponsor: University of Manchester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-10
• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2027-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Locally advanced cervical cancer patients treated with standard of care chemoradiation	MRI scans	-
Locally advanced cervical cancer patients treated with standard of care chemoradiation	Biopsy of tumour	-

Primary Outcome Measures

Name	Time	Method
MRI derived hypoxia scores on 20 participants	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.	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.

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, Greater Manchester, United Kingdom