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

NCT02512848 | Unknown

• 1 other identifier: XJTU1AHCR2014-007
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Neoplasms

Keywords

postmenopause; endometrial sampling; vaginal bleeding

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

endometrial neoplasms

patients with risk of endometrial cancer in the postmenopausal period

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

participants with risks of endometrial cancer in the postmenopausal period

You may qualify if:

• Postmenopausal abnormal uterine bleeding;
• Ultrasound of the pelvic showed thickened endometrial ( usually more than 5mm) ;
• Family history of endometrial cancers;
• Other participants with risks for endometrial cancer (such as fat, Lynch Syndrome and so on)

You may not qualify if:

• Cervical cancer;
• Fever (body's temperature is higher than 37.5 degrees );
• Vaginitis (excluding atrophic vaginitis);
• Patients who cannot bear the operation;
• Coagulation disorders;
• Pregnancy and suspected pregnancy.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (4)

• 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.

  PMID: 24331128 BACKGROUND

• 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.

  PMID: 22766754 BACKGROUND

• 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.

  PMID: 18548528 BACKGROUND

• 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.

  PMID: 18651884 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

endometrial sampling

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qiling Li, MD, PHD

  The First Affliated Hospital of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 31, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

CN (1)