A Liquid Biopsy Diagnostic Techniques for Endometriosis

• Conditions: Endometriosis; Liquid Biopsy

• Registration Number: NCT05749341
• Lead Sponsor: Tongji Hospital

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.

Study Timeline

• Study First Submitted: 2023-02-18
• Study First Submitted QC: 2023-02-18
• Study First Posted: 2023-03-01
• Study Start: 2023-04-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-24
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of cases with identified circulating endometrial cells.	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.

Trial Locations

Locations (1)

Wenwen Wang; 🇨🇳 Wuhan, Hubei, China