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

• Conditions: Endometrial Neoplasms

• Registration Number: NCT02512848
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-07-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-25
• Primary Completion: 2022-04
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the new diagnosis method with gold standard via Kappa statistic	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.

Trial Locations

Locations (1)

The First Affliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China