A Cohort Study for the Following up of Conization

NCT ID: NCT03961178

Last Updated: 2019-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-03

Study Completion Date

2021-05-22

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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High-risk HPV

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

Intervention Type DIAGNOSTIC_TEST

TCT

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, M.D.

Role: CONTACT

+8613911988831

Ming Wu, M.D.

Role: CONTACT

+8613911988831

Facility Contacts

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Lei Li, MD

Role: primary

008613911988831

Other Identifiers

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CONE

Identifier Type: -

Identifier Source: org_study_id

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