A Liquid Biopsy Diagnostic Techniques for Endometriosis

February 24, 2024 updated by: Wenwen Wang, Tongji Hospital

A Pilot Study of Liquid Biopsy Diagnostic Techniques for Endometriosis

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Wenwen Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Planned number of sample for each group: 20 with endometriosis and 20 without endometriosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of cases with identified circulating endometrial cells.
Time Frame: within one week after blood sample collecting

To evaluate the ability of the Three-Dimensional Poly(dimethylsiloxane) Scaffold to isolating circulating endometrial cells (CEC) in patients with and without endometriosis.

In each group, the percentage of cases with identified circulating endometrial cells will be estimated.
within one week after blood sample collecting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Study Director: WENWEN WANG, DOCTOR, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

February 18, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 24, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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