Significance of Fluorescence Colposcopy With Autofluorescence Imaging for Cervical Cancer

Completed

• Conditions: Cervical Cancer

• Registration Number: NCT01854983
• Lead Sponsor: Asan Medical Center

Brief Summary

Clinical Trial to access Significance of fluorescence colposcopy with autofluorescence imaging for the screening of cervical cancer

Detailed Description

1. Perform pelvic vaginal exam of the subjective to know symptom, illness history, physical exam and basal state before fluorescence colposcopy.

2. Observe acetowhite epithelium and perform biopsy at suspicious lesion during fluorescence colposcopy.

3. Perform fluorescence colposcopy again after biopsy and confirm extraordinary reaction.

4. After 1\~2weeks follow up the subjective at opd and confirm biopsy result.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-16
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-27
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. age : 20-65 years
2. abnormal cervical papanicolaou smear , no other specific cervical disease
3. subject to colposcopic biopsy or LEEP
4. signed voluntarily to informed concents with full knowledge after explanation abot objective, method, contents

Exclusion Criteria

1. pregnant women
2. porphyria
3. severe cervical bleeding
4. genital chlamydia, gonorrhea infection
5. other drug user with possible interaction (e.g. photosensitizer)
6. no informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fluorescence colposcopic result	2weeks after fluorescence colposcopy

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of