NCT01854983

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

May 14, 2013

Last Update Submit

May 27, 2017

Conditions

Cervical Cancer

Keywords

fluorescence colposcopycervical cancer

Outcome Measures

Primary Outcomes (1)

  • fluorescence colposcopic result

    2weeks after fluorescence colposcopy

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

tertiary center

You may qualify if:

  • age : 20-65 years
  • abnormal cervical papanicolaou smear , no other specific cervical disease
  • subject to colposcopic biopsy or LEEP
  • signed voluntarily to informed concents with full knowledge after explanation abot objective, method, contents

You may not qualify if:

  • pregnant women
  • porphyria
  • severe cervical bleeding
  • genital chlamydia, gonorrhea infection
  • other drug user with possible interaction (e.g. photosensitizer)
  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jeong-Yeol Park, M.D., Ph.D.

    Asan Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical assistant professor

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 16, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

KR(1)