Factors Associated With Residual Disease In The Central Cone

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03788850

Acronym

FARDCC

Enrollment

397

Registered

2018-12-28

Start date

2006-01-01

Completion date

2016-08-15

Last updated

2020-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Intraepithelial Neoplasia

Keywords

residual disease, central cone, predictive model

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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Identify the clinical and pathologic factors associated with residual disease	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.

Outcome results