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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: April 2022

Detailed 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.

Arms, Groups and Cohorts

  • endometrial neoplasms
    • patients with risk of endometrial cancer in the postmenopausal period

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • First Affiliated Hospital Xi’an Jiaotong University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Qiling Li, MD, PHD, Principal Investigator, The First Affliated Hospital of Xi’an Jiaotong University

References

Meads C, Sutton A, MaƂysiak 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.

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.

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.