NCT03961178

A Cohort Study for the Following up of Conization

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	High-risk HPV	High-risk HPV testing for the cytology of lower genital tract
DIAGNOSTIC_TEST	TCT	Thin prep liquid-based cytology test for the cytology of lower genital tract

Timeline

• Start date: 2019-06-03
• Primary completion: 2021-05-22
• Completion: 2021-05-22
• First posted: 2019-05-23
• Last updated: 2019-06-20

Locations

1 site across 1 country: China