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NCT05749341 Clinical Trial

A Liquid Biopsy Diagnostic Techniques for Endometriosis

Endometriosis Clinical Trial

Official title:
A Pilot Study of Liquid Biopsy Diagnostic Techniques for Endometriosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05749341
Other study ID # V1
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 10, 2023
Est. completion date March 31, 2024

Study information
Verified date February 2024
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 40
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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.

Locations
Country Name City State
China Wenwen Wang Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.		 within one week after blood sample collecting
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Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
Completed NCT02387931 - Supplementation in Adolescent Girls With Endometriosis Phase 4