Cervical CancerNCT01854983
Significance of Fluorescence Colposcopy With Autofluorescence Imaging for Cervical Cancer
An observational study of Cervical Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Clinical Trial to access Significance of fluorescence colposcopy with autofluorescence imaging for the screening of cervical cancer Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: tertiary center
Who may be able to join
- 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
Who cannot join
- pregnant women
- porphyria
- severe cervical bleeding
- genital chlamydia, gonorrhea infection
- other drug user with possible interaction (e.g. photosensitizer)
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
- Perform pelvic vaginal exam of the subjective to know symptom, illness history, physical exam and basal state before fluorescence colposcopy.
- Observe acetowhite epithelium and perform biopsy at suspicious lesion during fluorescence colposcopy.
- Perform fluorescence colposcopy again after biopsy and confirm extraordinary reaction.
- After 1~2weeks follow up the subjective at opd and confirm biopsy result.
- Conditions
- Cervical Cancer
- Keywords
- fluorescence colposcopy, cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
fluorescence colposcopic result
Measured: 2weeks after fluorescence colposcopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Yeol Park, Asan Medical Center
- Investigators
- Jeong-Yeol Park, M.D., Ph.D., Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854983
- Sponsor's protocol ID
- 2012-0693
- Status last verified
- May 2017
- First submitted
- 14 May 2013
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Access Significance of Fluorescence Colposcopy With Autofluorescence Imaging for the Screening of Cervical Cancer
- ClinicalTrials.gov ID
- NCT01854983
- Acronym / sponsor ID
- 2012-0693
- Conditions
- Cervical Cancer
- Keywords
- fluorescence colposcopy, cervical cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Trial to access Significance of fluorescence colposcopy with autofluorescence imaging for the screening of cervical cancer
Detailed description
- Perform pelvic vaginal exam of the subjective to know symptom, illness history, physical exam and basal state before fluorescence colposcopy.
- Observe acetowhite epithelium and perform biopsy at suspicious lesion during fluorescence colposcopy.
- Perform fluorescence colposcopy again after biopsy and confirm extraordinary reaction.
- After 1~2weeks follow up the subjective at opd and confirm biopsy result.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- pregnant women
- porphyria
- severe cervical bleeding
- genital chlamydia, gonorrhea infection
- other drug user with possible interaction (e.g. photosensitizer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fluorescence colposcopic result
Time frame: 2weeks after fluorescence colposcopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong-Yeol Park, M.D., Ph.D. study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluorescence colposcopic result (time frame: 2weeks after fluorescence colposcopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.