CClinicalTrials.gg
Enrolling by invitationNCT05749341Updated Feb 28, 2024

A Liquid Biopsy Diagnostic Techniques for Endometriosis

An observational study in Liquid Biopsy and Endometriosis, sponsored by Tongji Hospital. Enrolling by invitation at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Tongji Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 6 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
40
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Liquid Biopsy
  • Endometriosis

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03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's planned enrollment of 40 is below the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • Surgically and pathologically verified patients with or without endometriosis

Exclusion criteria

Exclusion Criteria:

  • suspicion of malignancy
  • pregnancy
  • acute infection
  • Lack of ability to sign informed consent forms on their own
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

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.

06

What researchers measure

Primary outcomes

  1. Percentage of cases with identified circulating endometrial cells.

    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.

    Time frame: within one week after blood sample collecting

07

Study locations

1 site
  • Wenwen Wang
    Wuhan, Hubei 430030, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05749341
Lead sponsor
Tongji Hospital
Responsible party
Wenwen Wang (associate professor, Tongji Hospital) — Principal investigator
First posted
Mar 1, 2023
Start date
Apr 10, 2023
Primary completion
Mar 31, 2024 (estimated)
Completion
Mar 31, 2024 (estimated)
Last update
Feb 28, 2024

Study contacts

WENWEN WANG, DOCTOR
study director · Huazhong University of Science and Technology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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