Cervical Intraepithelial Neoplasia Clinical Trial
— FARDCCOfficial title:
Factors Associated With Residual Disease In The Central Cone: A Disease Prediction Model
NCT number | NCT03788850 |
Other study ID # | 12102018INC |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2006 |
Est. completion date | August 15, 2016 |
Verified date | August 2020 |
Source | National Institute of Cancerología |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Cervical conization using the loop electrosurgical excision procedure (LEEP) is the standard treatment for patients with high-grade cervical intraepithelial neoplasia. Several studies have shown that excising a central cone reduces the rate of positive endocervical margins. The purpose of this study is to identify clinicopathological factors associated with residual disease in the central cone and to develop a predictive model to better determine which patients may require this additional procedure.
Status | Completed |
Enrollment | 397 |
Est. completion date | August 15, 2016 |
Est. primary completion date | December 31, 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - patients who underwent a loop electrosurgical excision procedure (LEEP) Exclusion Criteria: - a diagnosis of micro-invasion or nonsquamous histology - less than six months of follow-up - incomplete information in their clinical charts. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Institute of Cancerología |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identify the clinical and pathologic factors associated with residual disease | Whit the variables identified as factors associated with the residual disease develop a predictive model to determine which individuals may require additional procedures in the uterine cervix to ensure negative margins. | 1month |
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