Factors Associated With Residual Disease In The Central Cone (FARDCC)

August 25, 2020 updated by: David Cantu, National Institute of Cancerología

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

397

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients who underwent a cervical cone procedure at the Dysplasia Clinic of the Instituto Nacional de Cancerologia in Mexico City

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cancerología

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2006

Primary Completion (Actual)

December 31, 2011

Study Completion (Actual)

August 15, 2016

Study Registration Dates

First Submitted

November 5, 2018

First Submitted That Met QC Criteria

December 26, 2018

First Posted (Actual)

December 28, 2018

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12102018INC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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