Brief Title
Factors Associated With Residual Disease In The Central Cone
Official Title
Factors Associated With Residual Disease In The Central Cone: A Disease Prediction Model
Brief Summary
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.
Detailed Description
This study pretends to create a retrospective database including all patient who underwent a loop electrosurgical excision procedure by treatment for high-grade cervical intraepithelial neoplasia and create a a predictive model for top-hat resection in patients with high grade CIN
Study Type
Observational
Primary Outcome
Identify the clinical and pathologic factors associated with residual disease
Condition
Cervical Intraepithelial Neoplasia
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
397
Start Date
January 1, 2006
Completion Date
August 15, 2016
Primary Completion Date
December 31, 2011
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
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Administrative Informations
NCT ID
NCT03788850
Organization ID
12102018INC
Responsible Party
Principal Investigator
Study Sponsor
National Institute of Cancerología
Study Sponsor
, ,
Verification Date
August 2020