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

Endometrial Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02512848
• Other study ID #: XJTU1AHCR2014-007
• Status: Active, not recruiting
• Start date: April 2015
• Est. completion date: July 2022

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Neoplasms

Locations

Country	Name	City	State
China	The First Affliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (4)

Demirkiran F, Yavuz E, Erenel H, Bese T, Arvas M, Sanioglu C. Which is the best technique for endometrial sampling? Aspiration (pipelle) versus dilatation and curettage (D&C). Arch Gynecol Obstet. 2012 Nov;286(5):1277-82. doi: 10.1007/s00404-012-2438-8. Epub 2012 Jul 6. — View Citation

Kipp BR, Medeiros F, Campion MB, Distad TJ, Peterson LM, Keeney GL, Halling KC, Clayton AC. Direct uterine sampling with the Tao brush sampler using a liquid-based preparation method for the detection of endometrial cancer and atypical hyperplasia: a feasibility study. Cancer. 2008 Aug 25;114(4):228-35. doi: 10.1002/cncr.23636. — View Citation

Meads C, Sutton A, Malysiak S, Kowalska M, Zapalska A, Rogozinska E, Baldwin P, Rosenthal A, Ganesan R, Borowiack E, Barton P, Roberts T, Sundar S, Khan K. Sentinel lymph node status in vulval cancer: systematic reviews of test accuracy and decision-analytic model-based economic evaluation. Health Technol Assess. 2013 Dec;17(60):1-216. doi: 10.3310/hta17600. Review. — View Citation

Williams AR, Brechin S, Porter AJ, Warner P, Critchley HO. Factors affecting adequacy of Pipelle and Tao Brush endometrial sampling. BJOG. 2008 Jul;115(8):1028-36. doi: 10.1111/j.1471-0528.2008.01773.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one week within the enrollment