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Clinical Trials/NCT03961178
NCT03961178
Unknown
Not Applicable

Oncologic and Obstetric Outcomes After Conization for Uterine Cervical Lesion: A Cohort Study

Lei Li1 site in 1 country10,000 target enrollmentJune 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Precancerous Lesions
Sponsor
Lei Li
Enrollment
10000
Locations
1
Primary Endpoint
The cumulative incidences of precancerous lesions or cancers
Last Updated
6 years ago

Overview

Brief Summary

This study is to investigate the oncologic and obstetric outcomes in patients with conization for uterine cervical lesions from January 1, 2000 to January 1, 2019 in Peking Union Medical College Hospital.

The primary objectives consist of following:

  1. The cumulative incidences of precancerous lesions and cancers of lower genital tract in patients who accepted conization for high grade intraepithelial neoplasia (HSIL), carcinoma in situ and stage IA1 cancer (FIGO 2009)
  2. The cumulative pregnancy rates in patients sparing the fertility

The secondary objectives consist of following:

  1. The effects of surgical protocols (modified Sturmdorf method and "8" figure suture) and energy equipment (cold knife and monopolar electrical cautery) on the oncologic and obstetric outcomes, and on the histological components.
  2. A full description of histological components of the conization specimens
  3. The cytological and virus outcomes after conization, based on the thin prep liquid-based cytology test (TCT) and high-risk human papillomavirus (HPV) testing
Registry
clinicaltrials.gov
Start Date
June 3, 2019
End Date
May 22, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Lei Li
Responsible Party
Sponsor Investigator
Principal Investigator

Lei Li

Professor

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

  • Accepting conization in the study center
  • Aged 18 years or older

Exclusion Criteria

  • Not meeting any of the inclusion criteria

Outcomes

Primary Outcomes

The cumulative incidences of precancerous lesions or cancers

Time Frame: Five years

The cumulative incidences of precancerous lesions and cancers of lower genital track in patients who accepted conization for high grade intraepithelial neoplasia (HSIL), carcinoma in situ and stage IA1 cancer (FIGO 2009)

The cumulative pregnancy rates

Time Frame: Five years

The cumulative pregnancy rates in patients sparing the fertility

Secondary Outcomes

  • The cumulative live birth rates(Five years)
  • The virus outcomes after conization(Five years)
  • The cumulative pregnancy loss rates(Five years)
  • The cytological results after conization(Five years)

Study Sites (1)

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