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

NCT02512848UNKNOWNOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Enrollment

100

Start Date

2015-04-01

Completion Date

2022-04-01

Study Type

OBSERVATIONAL

Official Title

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

Conditions

Endometrial Neoplasms

Eligibility

Age Range

40 Years – 80 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Compare the new diagnosis method with gold standard via Kappa statistic

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.

Time frame: one week within the enrollment

Locations

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

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