A Cohort Study for the Following up of Conization

• Conditions: Pregnancy; Precancerous Lesions; Conization; Fertility; Uterine Cervical Cancer; Human Papillomavirus Infection; High Grade Intraepithelial Neoplasia

• Registration Number: NCT03961178
• Lead Sponsor: Lei Li

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Status Verified: 2019-06
• Study Start: 2019-06-03
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-06-20
• Primary Completion: 2021-05-22
• Study Completion: 2021-05-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10000

Inclusion Criteria

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

Exclusion Criteria

• Not meeting any of the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The cumulative incidences of precancerous lesions or cancers	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	Five years	The cumulative pregnancy rates in patients sparing the fertility

Secondary Outcome Measures

Name	Time	Method
The cumulative live birth rates	Five years	The cumulative live birth rates in patients sparing the fertility
The virus outcomes after conization	Five years	The virus outcomes after conization high-risk human papillomavirus (HPV) testing
The cumulative pregnancy loss rates	Five years	The cumulative pregnancy loss rates in patients sparing the fertility
The cytological results after conization	Five years	The cytological after conization based on the thin prep liquid-based cytology test (TCT)

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China