A Liquid Biopsy Diagnostic Techniques for Endometriosis

NCT ID: NCT05749341

Last Updated: 2024-02-28

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

ENROLLING_BY_INVITATION

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-10

Study Completion Date

2024-03-31

Brief Summary

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To evaluate the diagnostic efficiency of circulating endometrial cell detection method using microfluidic chip as an non-invasive method for diagnosis in endometriosis.

Detailed Description

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Endometriosis is a chronic condition, characterized by the presence of functional endometrial glands and interstitium in extrauterine ectopia. Ectopic endometrial tissue responds to estradiol and other hormones similar to normal endometrium. Endometriosis is one of the most common benign gynaecological conditions, affecting up to 5 to 10 percent of women of reproductive age. In addition to severe dysmenorrhea or pelvic pain, decreased fertility is a common clinical manifestation of internal heterogeneity, with up to 40 percent of patients associated with infertility . Currently, laparoscopy is the gold standard for diagnosis. However, the actual time to diagnosis in patients with internal dysmorphia is delayed by an average of 4 to 11 years, resulting in a large number of patients with moderate to severe (stage III to IV) at diagnosis. Recently, the exploration of efficient and cost-effective non-invasive diagnostic solutions has been a hot button issue.

Conditions

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Liquid Biopsy Endometriosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Three-Dimensional Poly(dimethylsiloxane) Scaffold

The rest blood samples from patients with and without endometriosis (No. 20 VS 20) would be collected for testing on a Microchip Embedded with Three-Dimensional Poly(dimethylsiloxane) Scaffold.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

• Surgically and pathologically verified patients with or without endometriosis

Exclusion Criteria

* suspicion of malignancy
* pregnancy
* acute infection
* Lack of ability to sign informed consent forms on their own
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wenwen Wang

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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WENWEN WANG, DOCTOR

Role: STUDY_DIRECTOR

Huazhong University of Science and Technology

Locations

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Wenwen Wang

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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V1

Identifier Type: -

Identifier Source: org_study_id

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