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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary: 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.
Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: First Affiliated Hospital Xi'an Jiaotong University

Dates:
Date Received: July 8, 2015
Date Started: April 2015
Date Completion: July 2017
Last Updated: August 14, 2016
Last Verified: August 2016