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

NCT ID: NCT02512848

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2022-07-31

Brief Summary

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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 Description

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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.

Conditions

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Endometrial Neoplasms

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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endometrial neoplasms

patients with risk of endometrial cancer in the postmenopausal period

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qiling Li, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

The First Affliated Hospital of Xi'an Jiaotong University

Locations

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The First Affliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 24331128 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22766754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18548528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18651884 (View on PubMed)

Other Identifiers

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XJTU1AHCR2014-007

Identifier Type: -

Identifier Source: org_study_id

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