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A Cohort Study for the Following up of Conization

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03961178
Enrollment
10000
Registered
2019-05-23
Start date
2019-06-03
Completion date
2021-05-22
Last updated
2019-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conization, Fertility, High Grade Intraepithelial Neoplasia, Human Papillomavirus Infection, Precancerous Lesions, Pregnancy, Uterine Cervical Cancer

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

Interventions

DIAGNOSTIC_TESTHigh-risk HPV

High-risk HPV testing for the cytology of lower genital tract

DIAGNOSTIC_TESTTCT

Thin prep liquid-based cytology test for the cytology of lower genital tract

Sponsors

Lei Li
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Not meeting any of the inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
The cumulative incidences of precancerous lesions or cancersFive yearsThe 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 ratesFive yearsThe cumulative pregnancy rates in patients sparing the fertility

Secondary

MeasureTime frameDescription
The cytological results after conizationFive yearsThe cytological after conization based on the thin prep liquid-based cytology test (TCT)
The virus outcomes after conizationFive yearsThe virus outcomes after conization high-risk human papillomavirus (HPV) testing
The cumulative pregnancy loss ratesFive yearsThe cumulative pregnancy loss rates in patients sparing the fertility
The cumulative live birth ratesFive yearsThe cumulative live birth rates in patients sparing the fertility

Countries

China

Contacts

Primary ContactLei Li, M.D.
lileigh@163.com+8613911988831
Backup ContactMing Wu, M.D.
wuming@pumch.cn+8613911988831

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026