Significance of Fluorescence Colposcopy With Autofluorescence Imaging for Cervical Cancer

NCT ID: NCT01854983

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cervical Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Yeol Park

clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong-Yeol Park, M.D., Ph.D.

Role: STUDY_CHAIR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2012-0693

Identifier Type: -

Identifier Source: org_study_id

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