The Feasibility Study of the Li Brush for the Screening of Endometrial Cancer in the Postmenopausal Period

August 19, 2021 updated by: First Affiliated Hospital Xi'an Jiaotong University

The Feasibility Study of Li Brush for the Screening of Endometrial Cancer in the Postmenopausal Period

Investigators aim to collect endometrial sampling with Li Brush among target population who have risks for endometrial neoplasm, then Fractional curettage should performed with these participants, investigators intend to compare the pathological diagnosis results of cytology and fractional curettage to evaluate the sensitivity of Li Brush and investigators expect that the brush can be used for screening of endometrial cancer in the postmenopausal period in the clinic.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Investigators screen the suitable participants according to the inclusion and exclusion standards, and then collect their endometrial sampling with Li Brush. Pathologists will help to decide the cytology obtained by Li Brush and histology diagnosis of the endometrial sampling. Comparing the pathological diagnosis results of cytology and histology, investigators want to prove the feasibility of cytology diagnosis of endometrial cancer in the postmenopausal period, as the same time, investigators intend to evaluate the possible factors that affecting the precision of Li Brush for endometrial cancer in the postmenopausal period.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

participants with risks of endometrial cancer in the postmenopausal period

Description

Inclusion Criteria:

  1. Postmenopausal abnormal uterine bleeding;
  2. Ultrasound of the pelvic showed thickened endometrial ( usually more than 5mm) ;
  3. Family history of endometrial cancers;
  4. Other participants with risks for endometrial cancer (such as fat, Lynch Syndrome and so on)

Exclusion Criteria:

  1. Cervical cancer;
  2. Fever (body's temperature is higher than 37.5 degrees );
  3. Vaginitis (excluding atrophic vaginitis);
  4. Patients who cannot bear the operation;
  5. Coagulation disorders;
  6. Pregnancy and suspected pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
endometrial neoplasms
patients with risk of endometrial cancer in the postmenopausal period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the new diagnosis method with gold standard via Kappa statistic
Time Frame: one week within the enrollment
Kappa statistic will be used to access the agreement of the two diagnosis results. The diagnosis result is dichotomous data: having endometrial cancer or not. The safety risk is the same as it of the gold standard.
one week within the enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Qiling Li, MD, PHD, The First Affliated Hospital of Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AHCR2014-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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