The Feasibility Study of the Li Brush for the Screening of Endometrial Cancer in the Postmenopausal Period
This trial is active, not recruiting.
|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.
Compare the new diagnosis method with gold standard via Kappa statistic
time frame: one week within the enrollment
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.
|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.|
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