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A Cohort Study for the Following up of Conization

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ClinicalTrials.gov Identifier: NCT03961178
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

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. 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

Condition or disease Intervention/treatment
Precancerous Lesions Conization High Grade Intraepithelial Neoplasia Uterine Cervical Cancer Fertility Pregnancy Human Papillomavirus Infection Diagnostic Test: High-risk HPV Diagnostic Test: TCT

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Oncologic and Obstetric Outcomes After Conization for Uterine Cervical Lesion: A Cohort Study
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : May 22, 2021
Estimated Study Completion Date : May 22, 2021

Intervention Details:
  • 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


Primary Outcome Measures :
  1. The cumulative incidences of precancerous lesions or cancers [ Time Frame: Five years ]
    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)

  2. The cumulative pregnancy rates [ Time Frame: Five years ]
    The cumulative pregnancy rates in patients sparing the fertility


Secondary Outcome Measures :
  1. The cytological results after conization [ Time Frame: Five years ]
    The cytological after conization based on the thin prep liquid-based cytology test (TCT)

  2. The virus outcomes after conization [ Time Frame: Five years ]
    The virus outcomes after conization high-risk human papillomavirus (HPV) testing

  3. The cumulative pregnancy loss rates [ Time Frame: Five years ]
    The cumulative pregnancy loss rates in patients sparing the fertility

  4. The cumulative live birth rates [ Time Frame: Five years ]
    The cumulative live birth rates in patients sparing the fertility



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not meeting any of the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961178


Contacts
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Contact: Lei Li, M.D. +8613911988831 lileigh@163.com
Contact: Ming Wu, M.D. +8613911988831 wuming@pumch.cn

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    008613911988831    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Investigators
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Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital

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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03961178     History of Changes
Other Study ID Numbers: CONE
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Carcinoma in Situ
Papillomavirus Infections
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Virus Diseases
Tumor Virus Infections