Recurrence in High-grade Lesions After Conization

Cervical Intraepithelial Neoplasia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540421
• Other study ID #: CIN1701
• Status: Completed
• Phase: N/A
• First received: October 15, 2014
• Last updated: September 1, 2015
• Start date: January 2001
• Est. completion date: December 2007

Study information

• Verified date: September 2015
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. history of surgery for conization

Exclusion Criteria:

1. under 18 years of age,

2. immunosuppressed,

3. Patient with a histopathological diagnosis of low-grade intraepithelial neoplasia

4. Patient with invasion, or surgical margins obtained by LLETZ that were unable to be evaluated.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

Locations

Country	Name	City	State
Brazil	Emerson de Oliveira	Santo Andre	SP

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rates after conization	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	12 months	No