This trial is active, not recruiting.

Condition endometrial neoplasms
Sponsor First Affiliated Hospital Xi'an Jiaotong University
Start date April 2015
End date April 2017
Trial size 100 participants
Trial identifier NCT02512848, XJTU1AHCR2014-007


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.

United States No locations recruiting
Other countries No locations recruiting

Primary Outcomes

Compare the new diagnosis method with gold standard via Kappa statistic
time frame: one week within the enrollment

Eligibility Criteria

Female participants from 40 years up to 80 years old.

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.

Additional Information

Official title The Feasibility Study of Li Brush for the Screening of Endometrial Cancer in the Postmenopausal Period
Principal investigator Qiling Li, MD, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by First Affiliated Hospital Xi'an Jiaotong University.