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OpenTrials
Completed

NCT Number: NCT02540421

Recurrence in High-grade Lesions After Conization

Objectives: To identify factors associated with disease recurrence in patients with high-grade cervical intra-epithelial neoplasia (CIN) undergoing large loop excision of the transformation zone (LLETZ).

Study Design: A case-control study that included 103 patients. Patients were included in the study if they had a history of surgery for conization by LLETZ for the histopathological diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III). Follow-up exams were conducted every six months with Pap smear collection and colposcopic examination with biopsy, when necessary, for a minimum period of twelve months. Cure was defined as a normal follow-up examination within 24 months. During follow-up, relapse occurred when cytology and/or biopsy results showed that CIN had returned after 12 months, at which time a new cervical conization by LLETZ was performed.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Emerson de Oliveira

Santo André, São Paulo, 09080301, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • history of surgery for conization

Exclusion criteria

  • under 18 years of age,
  • immunosuppressed,
  • Patient with a histopathological diagnosis of low-grade intraepithelial neoplasia
  • Patient with invasion, or surgical margins obtained by LLETZ that were unable to be evaluated.

Treatment and study plan

Primary outcomes

  1. Recurrence rates after conization

    Time frame: 12 months

    Number of patients who are regarded as recurrence based on the following criteria:

    • relapse occurred when cytology and/or biopsy showed that CIN had returned after 12 months

Sponsors and collaborators

Lead sponsor

Faculdade de Medicina do ABC

Other

Registry information

Official study title

Presence of Positive Resection Margins, Hypooestrogenism and Specimen Volume May Influence Risk of Disease Recurrence in Patients With High-grade Cervical Intra-epithelial Neoplasia Undergoing Large Loop Excision of the Transformation Zone

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Sep 4, 2015
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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