A Cohort Study for the Following up of Conization

Lei Li

Status: Unknown

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

Treatments: Diagnostic Test: High-risk HPV; Diagnostic Test: TCT

Study type: Observational

Funder types: Other

Identifiers

NCT03961178

CONE

Details and patient eligibility

About

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

Enrollment: 10,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Not meeting any of the inclusion criteria