Factors Associated With Residual Disease In The Central Cone

NCT ID: NCT03788850

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 397 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-01
• Study Completion Date: 2016-08-15

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

Conditions

Cervical Intraepithelial Neoplasia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Cancerología

OTHER_GOV

Sponsor Role: lead

Responsible Party

David Cantu

Chief of clinical trial departament

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

12102018INC

Identifier Type: -

Identifier Source: org_study_id