Precancerous LesionsNCT03961178
A Cohort Study for the Following up of Conization
An observational study of Precancerous Lesions and Conization, run by Lei Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Precancerous Lesions, Conization, High Grade Intraepithelial Neoplasia
- What is being tested?
- High-risk HPV and TCT
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2019to 22 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients accepting conization in the study center who were aged 18 years or older.
Who may be able to join
- Accepting conization in the study center
- Aged 18 years or older
Who cannot join
- Not meeting any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
Official title: Oncologic and Obstetric Outcomes After Conization for Uterine Cervical Lesion: A Cohort Study
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:
Read more
- 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)
- The cumulative pregnancy rates in patients sparing the fertility
The secondary objectives consist of following:
- 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.
- A full description of histological components of the conization specimens
- 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
- Being tested
- High-risk HPV, TCT
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-risk HPVDiagnostic test
High-risk HPV testing for the cytology of lower genital tract
TCTDiagnostic test
Thin prep liquid-based cytology test for the cytology of lower genital tract
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Five years
The cumulative pregnancy rates
The cumulative pregnancy rates in patients sparing the fertility
Measured: Five years
Secondary outcomes (4)
The cytological results after conization
The cytological after conization based on the thin prep liquid-based cytology test (TCT)
Measured: Five years
The virus outcomes after conization
The virus outcomes after conization high-risk human papillomavirus (HPV) testing
Measured: Five years
The cumulative pregnancy loss rates
The cumulative pregnancy loss rates in patients sparing the fertility
Measured: Five years
The cumulative live birth rates
The cumulative live birth rates in patients sparing the fertility
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start3 Jun 2019
- Primary completion22 May 2021 (estimated)
- Study completion22 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precancerous LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961178
- Sponsor's protocol ID
- CONE
- Status last verified
- Jun 2019
- First submitted
- 22 May 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncologic and Obstetric Outcomes After Conization for Uterine Cervical Lesion: A Cohort Study
- ClinicalTrials.gov ID
- NCT03961178
- Acronym / sponsor ID
- CONE
- Conditions
- Precancerous Lesions, Conization, High Grade Intraepithelial Neoplasia, Uterine Cervical Cancer, Fertility, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 22 May 2021 (estimated)
- Study completion
- 22 May 2021 (estimated)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
- The cumulative pregnancy rates in patients sparing the fertility
The secondary objectives consist of following:
- 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.
- A full description of histological components of the conization specimens
- The cytological and virus outcomes after conization, based on the thin prep liquid-based cytology test (TCT) and high-risk human papillomavirus (HPV) testing
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients accepting conization in the study center who were aged 18 years or older.
Key inclusion criteria (2 listed)
- Accepting conization in the study center
- Aged 18 years or older
Key exclusion criteria (1 listed)
- Not meeting any of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-risk HPVHigh-risk HPV testing for the cytology of lower genital tract | Diagnostic test | – |
| TCTThin prep liquid-based cytology test for the cytology of lower genital tract | Diagnostic test | – |
Primary outcome
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)
The cumulative pregnancy rates
Time frame: Five years
The cumulative pregnancy rates in patients sparing the fertility
4 secondary outcomes
The cytological results after conization
Time frame: Five years
The virus outcomes after conization
Time frame: Five years
The cumulative pregnancy loss rates
Time frame: Five years
The cumulative live birth rates
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Precancerous Lesions and Conization, run by Lei Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li, M.D. (+8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cumulative incidences of precancerous lesions or cancers (time frame: Five years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.