A Cohort Study for the Following up of Conization

NCT03961178 | Unknown

• 1 other identifier: CONE
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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. 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. 2.The cumulative pregnancy rates in patients sparing the fertility
3. 3.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.
4. 4.A full description of histological components of the conization specimens
5. 5.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

Outcome Measures

Primary Outcomes (2)

• The cumulative incidences of precancerous lesions or cancers

  The 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)

  Five years

• The cumulative pregnancy rates

  The cumulative pregnancy rates in patients sparing the fertility

  Five years

Secondary Outcomes (4)

• The cytological results after conization

  Five years

• The virus outcomes after conization

  Five years

• The cumulative pregnancy loss rates

  Five years

• The cumulative live birth rates

  Five years

Interventions

High-risk HPV DIAGNOSTIC_TEST

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

TCT DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients accepting conization in the study center who were aged 18 years or older.

You may qualify if:

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

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

+8613911988831; lileigh@163.com

Ming Wu, M.D.

CONTACT

+8613911988831; wuming@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 23, 2019
• Study Start: June 3, 2019
• Primary Completion: May 22, 2021
• Study Completion: May 22, 2021
• Last Updated: June 20, 2019

Record last verified: 2019-06

Locations

CN (1)