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A Cohort Study for the Following up of Conization

NCT03961178 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2019-06-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Lei Li

    lead OTHER

Principal Investigators

  • Lei Li, M.D. · Peking Union Medical College Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2021-05-22
Completion
2021-05-22

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03961178 on ClinicalTrials.gov