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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2020
Source National Institute of Cancerología
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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