Cell-Based Noninvasive Prenatal Testing

Not Applicable

Recruiting

• Conditions: Pregnancy Related
• Interventions: Diagnostic Test: Redraw for analysis of blood samples from healthy pregnant women

• Registration Number: NCT05245266
• Lead Sponsor: Luna Genetics

Brief Summary

The purpose of the overall study is to develop improved methods for recovery and analysis of fetal cells from the mother's blood in order to develop clinically useful forms of cell-based, diagnostic, noninvasive prenatal testing (NIPT). Luna genetics will obtain and analyze research blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood samples. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-12
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-17
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-27
• Primary Completion: 2024-01-12
• Study Completion: 2024-03-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Analysis of blood samples from healthy pregnant women	Redraw for analysis of blood samples from healthy pregnant women	Analysis of blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood sample. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers. No information will go back to patients or their physicians.

Primary Outcome Measures

Name	Time	Method
Number of fetal cells recovered and quality of DNA data on each cell	3 years	Outcome measure 2 is the number of cells that yield high quality next generation; sequencing data suitable for determining copy number across the entire genome. So if 4 of the 8 cells above gave high quality data, the outcome would be 4 cells with high quality copy number data from one blood draw which equals 0.10 high quality cell / mL of mother's b

Trial Locations

Locations (1)

Luna Genetics; 🇺🇸 Houston, Texas, United States