Factors Associated With Residual Disease In The Central Cone

Cervical Intraepithelial Neoplasia Clinical Trial

— FARDCC  

Official title:

Factors Associated With Residual Disease In The Central Cone: A Disease Prediction Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03788850
• Other study ID #: 12102018INC
• Status: Completed
• Start date: January 1, 2006
• Est. completion date: August 15, 2016

Study information

• Verified date: August 2020
• Source: National Institute of Cancerología
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cancerología

Outcome

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