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

Monitoring of cervical lesions at colposcopy using a novel non-invasive technique for monitoring of CIN2 lesions (a pilot/feasibility study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30282356
Enrollment
10
Registered
2022-01-27
Start date
2021-04-07
Completion date
Unknown
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical intraepithelial neoplasia [CIN], grade II Urological and Genital Diseases Cervical intraepithelial neoplasia [CIN], grade II

Interventions

If enrolled on the study after CIN2 diagnosis: 1. Primary visit for colposcopy – CIN2 identified, acetowhite photograph and Patch taken followed by biopsy 2. 3-month visit for colposcopy – Patch, ace

Sponsors

Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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) 2. Biomarker patterns consistent with lesion regression/progression identified using immunohistochemistry at 0, 3, 6, 9 and 12 months

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026