Monitoring of precancerous cervical lesions at colposcopy using a new non-invasive technique

Not Applicable

Completed

• Conditions: Cervical intraepithelial neoplasia [CIN], grade II; Urological and Genital Diseases

• Registration Number: ISRCTN30282356
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-27
• Study Completion: 2022-12-31
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 14

Inclusion Criteria

All patients who are <35 years of age AND are CIN2 positive on biopsy AND have only single quadrant disease

Exclusion Criteria

1. Patients >35 years
2. Patients who are pregnant
3. Patients who are immunosuppressed/are HIV positive
4. Patients who cannot give informed consent
5. Patients who are allergic to nail varnish/have been told they are allergic to nitrocellulose

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. CIN2 lesions identified using colposcopy/cytology/histology and cell lift at 0 months (colposcopy cell lift and biopsy), 3 months (colposcopy and cell lift), 6 months (colposcopy, cytology and cell lift), 9 months (colposcopy and cell lift), and 12 months colposcopy cell lift and biopsy)<br>2. Biomarker patterns consistent with lesion regression/progression identified using immunohistochemistry at 0, 3, 6, 9 and 12 months

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures