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

N

National Institute of Cancerología

Status

Completed

Conditions

Cervical Intraepithelial Neoplasia

Study type

Observational

Funder types

Other

Identifiers

NCT03788850
12102018INC

Details and patient eligibility

About

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.

Full 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

Enrollment

397 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No 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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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