Optical vulvar biopsy by optical coherence tomography (OCT)

Completed

• Conditions: premalignant vulvar cancer; 10038594

• Registration Number: NL-OMON34664
• Lead Sponsor: ederlands Kanker Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Patients with suspicion of vulvar intraepithelial neoplasia
Patients with vulvar cancer

Exclusion Criteria

Patients without suspicion of vulvar intraepithelial neoplasia
Patients without vulvar cancer

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the sensitivity, specificity, positive predictive and negative<br /><br>predictive value of OCT for the presence of VIN and invasive cancer in patients<br /><br>with suspicion of VIN or vulvar cancer.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>na</p><br>