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NCT03961178 Clinical Trial

A Cohort Study for the Following up of Conization

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03961178
Other study ID # CONE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 3, 2019
Est. completion date May 22, 2021

Study information
Verified date June 2019
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone +8613911988831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date May 22, 2021
Est. primary completion date May 22, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Accepting conization in the study center

- Aged 18 years or older

Exclusion Criteria:

- Not meeting any of the inclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• High-risk HPV
High-risk HPV testing for the cytology of lower genital tract
• TCT
Thin prep liquid-based cytology test for the cytology of lower genital tract

Locations
Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The cumulative incidences of precancerous lesions or cancers 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) Five years
Primary The cumulative pregnancy rates The cumulative pregnancy rates in patients sparing the fertility Five years
Secondary The cytological results after conization The cytological after conization based on the thin prep liquid-based cytology test (TCT) Five years
Secondary The virus outcomes after conization The virus outcomes after conization high-risk human papillomavirus (HPV) testing Five years
Secondary The cumulative pregnancy loss rates The cumulative pregnancy loss rates in patients sparing the fertility Five years
Secondary The cumulative live birth rates The cumulative live birth rates in patients sparing the fertility Five years
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