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

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ClinicalTrials.gov Identifier: NCT03788850
Recruitment Status : Completed
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
David Cantu, National Institute of Cancerología

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.

Condition or disease
Cervical Intraepithelial Neoplasia

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

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Study Type : Observational
Actual Enrollment : 397 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Factors Associated With Residual Disease In The Central Cone: A Disease Prediction Model
Actual Study Start Date : January 1, 2006
Actual Primary Completion Date : December 31, 2011
Actual Study Completion Date : August 15, 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of clinicopathologic factors associated with residual disease [ Time Frame: 1month ]
    Develop a predictive model to determine which individuals may require additional procedures in the uterine cervix to ensure negative margins



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Criteria

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.

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Responsible Party: David Cantu, Chief of clinical trial departament, National Institute of Cancerología
ClinicalTrials.gov Identifier: NCT03788850     History of Changes
Other Study ID Numbers: 12102018INC
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Cantu, National Institute of Cancerología:
residual disease
central cone
predictive model
Additional relevant MeSH terms:
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Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type