- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00985309
Clinical Parameters Predicting Unsatisfactory Cervicovaginal Cytology in Conventional Smears
September 25, 2009 updated by: Taichung Veterans General Hospital
According the terminology of Bethesda 2001, the unsatisfactory cervical cytology can be categorized into specimen rejected, or specimen processed and examined, but unsatisfactory for evaluation of epithelial abnormality.
Most of the unsatisfactory cervical cytology was due to scanty epithelial cells, which was defined by less than an estimated 8,000 to 12,000 well-visualized squamous cells for conventional smears.
Follow-up of unsatisfactory smear found an increased rate of cervical preinvasive and invasive lesions.
Thus, an unsatisfactory smear deserves careful follow-up and studies.
Although the Bethesda system allows criteria modification in cases of hysterectomy, pelvic irradiation therapy, or chemotherapy, no studies investigated the clinical factors related to the incidence of unsatisfactory smear.
Thus, the investigators designed this trial to study the clinical factors relating to unsatisfactory cervicovaginal smear.The list of patients who received Papanicolaou smear between March 2006 and August 2006 in our hospital will be obtained from the Pathological Department first.
Then the investigators will review the medical records from HIS system and pathologic files of these patients.
On estimation, 7,437 cases will be enrolled for analysis.
Clinical parameters for analysis include: age, gravidity, parity, abortion, menopause, location of Pap smear, history of pelvic malignancy, pelvic irradiation, cervical conization, hysterectomy; at pregnancy; three months postpartum; vaginal bleeding, vaginal abnormal discharge, intrauterine device, and cervical polyp found during pelvic examinations.
Patients who missed any of above data will be excluded for analysis.
The investigators will use univariate and multivariate analysis for data processing and statistic analysis to find out the relationship between clinical parameters and unsatisfactory cervicovaginal Pap smears.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taichung, Taiwan, 407
- Department of OB/GYN, Taichung Veterans General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
A cohort of consecutive patients who received conventional Pap smear between March 2006 and August 2006 in Taichung Veterans General Hospital
Description
Inclusion Criteria:
- A cohort of consecutive patients who received conventional Pap smear between March 2006 and August 2006 in Taichung Veterans General Hospital
Exclusion Criteria:
- nil
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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unsatisfactory Pap smear rates in various clinical conditions
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 24, 2009
First Submitted That Met QC Criteria
September 25, 2009
First Posted (Estimate)
September 28, 2009
Study Record Updates
Last Update Posted (Estimate)
September 28, 2009
Last Update Submitted That Met QC Criteria
September 25, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- C08213
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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