Clinical Trial to Access Significance of Fluorescence Colposcopy With Autofluorescence Imaging for the Screening of Cervical Cancer
20 Years
65 Years
Female
Cervical Cancer
Trial Information
Clinical Trial to Access Significance of Fluorescence Colposcopy With Autofluorescence Imaging for the Screening of Cervical Cancer
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
fluorescence colposcopic result
Outcome Time Frame:
2weeks after fluorescence colposcopy
Safety Issue:
Yes
Principal Investigator
Jeong-Yeol Park, M.D., Ph.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Asan Medical Center
Authority:
South Korea: Institutional Review Board
Study ID:
2012-0693
NCT ID:
NCT01854983
Start Date:
May 2013
Completion Date:
December 2013
Related Keywords:
- Cervical Cancer
- fluorescence colposcopy
- cervical cancer
- Uterine Cervical Neoplasms
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