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Significance of Fluorescence Colposcopy With Autofluorescence Imaging for Cervical Cancer

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ClinicalTrials.gov Identifier: NCT01854983
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Jeong-Yeol Park, Asan Medical Center

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

Condition or disease
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 Type : Observational
Actual Enrollment : 80 participants
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
Study Start Date : May 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer




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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older 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

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

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 Posted: May 16, 2013    Key Record Dates
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