NCT05749341

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

February 18, 2023

Last Update Submit

February 24, 2024

Conditions

Liquid BiopsyEndometriosis

Outcome Measures

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.

    within one week after blood sample collecting

Interventions

Three-Dimensional Poly(dimethylsiloxane) ScaffoldDIAGNOSTIC_TEST

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Surgically and pathologically verified patients with or without endometriosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenwen Wang

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Identify endometrial cell from peripheral blood sample

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • WENWEN WANG, DOCTOR

    Huazhong University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 1, 2023

Study Start

April 10, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

CN(1)