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Significance of Fluorescence Colposcopy With Autofluorescence Imaging for Cervical Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01854983
First Posted: May 16, 2013
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeong-Yeol Park, Asan Medical Center
  Purpose
Clinical Trial to access Significance of fluorescence colposcopy with autofluorescence imaging for the screening of cervical cancer

Condition
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Trial to Access Significance of Fluorescence Colposcopy With Autofluorescence Imaging for the Screening of Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Jeong-Yeol Park, Asan Medical Center:

Primary Outcome Measures:
  • fluorescence colposcopic result [ Time Frame: 2weeks after fluorescence colposcopy ]

Enrollment: 80
Study Start Date: May 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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.
  Eligibility

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
tertiary center
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854983


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Study Chair: Jeong-Yeol Park, M.D., Ph.D. Asan Medical Center
  More Information

Responsible Party: Jeong-Yeol Park, clinical assistant professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01854983     History of Changes
Other Study ID Numbers: 2012-0693
First Submitted: May 14, 2013
First Posted: May 16, 2013
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Jeong-Yeol Park, Asan Medical Center:
fluorescence colposcopy
cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female