NCT03788850

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2011

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

6 years

First QC Date

November 5, 2018

Last Update Submit

August 25, 2020

Conditions

Cervical Intraepithelial Neoplasia

Keywords

residual diseasecentral conepredictive model

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • patients who underwent a loop electrosurgical excision procedure (LEEP)

You may not qualify if:

  • a diagnosis of micro-invasion or nonsquamous histology
  • less than six months of follow-up
  • incomplete information in their clinical charts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical DysplasiaNeoplasm, Residual

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of clinical trial departament

Study Record Dates

First Submitted

November 5, 2018

First Posted

December 28, 2018

Study Start

January 1, 2006

Primary Completion

December 31, 2011

Study Completion

August 15, 2016

Last Updated

August 27, 2020

Record last verified: 2020-08