Significance of Fluorescence Colposcopy With Autofluorescence Imaging for Cervical Cancer

May 27, 2017 updated by: Jeong-Yeol Park, Asan Medical Center

Clinical Trial to Access Significance of Fluorescence Colposcopy With Autofluorescence Imaging for the Screening of Cervical Cancer

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

tertiary center

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fluorescence colposcopic result
Time Frame: 2weeks after fluorescence colposcopy
2weeks after fluorescence colposcopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jeong-Yeol Park, M.D., Ph.D., Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (ESTIMATE)

May 16, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 27, 2017

Last Verified

May 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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