Recurrence in High-grade Lesions After Conization
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
1 other identifier
observational
103
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2001
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 15, 2014
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedSeptember 4, 2015
September 1, 2015
6 years
October 15, 2014
September 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Case
Recurrent lesions
Control
Absence of lesions
Eligibility Criteria
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).
You may qualify if:
- \. history of surgery for conization
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emerson de Oliveira
Santo André, São Paulo, 09080301, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
EMERSON OLIVEIRA, PhD
FACULTY OF MEDICINE OF ABC
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
October 15, 2014
First Posted
September 4, 2015
Study Start
January 1, 2001
Primary Completion
January 1, 2007
Study Completion
December 1, 2007
Last Updated
September 4, 2015
Record last verified: 2015-09