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A Liquid Biopsy Diagnostic Techniques for Endometriosis

A Pilot Study of Liquid Biopsy Diagnostic Techniques for Endometriosis

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05749341
Enrollment
40
Registered
2023-03-01
Start date
2023-04-10
Completion date
2024-03-31
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis, Liquid Biopsy

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTThree-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.

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of cases with identified circulating endometrial cells.within one week after blood sample collectingTo 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026