Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
United Kingdom
The Christie NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
Rachel Reed, MSc
rachel.reed@manchester.ac.uk
01619187029
Backup
Kimberley Reeves, PhD
kimberley.reeves@manchester.ac.uk
Time Frame
Start Date: 2020-12-10
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 30
Treatments
Locally advanced cervical cancer patients treated with standard of care chemoradiation
Related Therapeutic Areas
Sponsors
Collaborators: The Christie NHS Foundation Trust
Leads: University of Manchester

This content was sourced from clinicaltrials.gov