Factors Associated With Residual Disease In The Central Cone

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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasm, Residual Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Identify the clinical and pathologic factors associated with residual disease

Time frame: 1month

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.

Sponsors and collaborators

Lead sponsor

National Institute of Cancerología

Other Gov

Registry information

Official study title

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

Acronym: FARDCC

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2016
First posted: Dec 28, 2018
Registry last updated: Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed