Cell-Based Noninvasive Prenatal Testing

Pregnancy Related Clinical Trial

— NIPT  

Official title:

Improving Methods for Cell-Based Noninvasive Prenatal Testing (NIPT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05245266
• Other study ID #: Luna IRB LG-003
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: March 12, 2024

Study information

• Verified date: March 2023
• Source: Luna Genetics
• Contact: April O' Connor, MS, LCGC
• Phone: 928-533-2429
• Email: aoconnor[@]lunagenetics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 12, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria for healthy pregnant subjects:

• Pregnant

• 18 years or older

• 65 or younger

Exclusion Criteria for healthy pregnant subjects:

• Acute illness

• Unavailability of maternal blood sample of at least 30 ml

• Language barrier (non-English speaking )

• Maternal age of less than 18 years, or over 65

• Higher order multiple pregnancy (triplet or greater)

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Diagnostic Test:
• Redraw for analysis of blood samples from healthy pregnant women
If less than two fetal cells are recovered from maternal blood, a redraw is indicated

Locations

Country	Name	City	State
United States	Luna Genetics	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Luna Genetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of fetal cells recovered and quality of DNA data on each cell	Outcome 1 is the number of cells identified as fetal by microscopic staining. This can be; converted to units based on volume. If 40 mL of blood is collected and f8 cells are designated as fetal based on microscopic staining, the results can be tabulated as follow: So a result is 8 cells are identified as fetal from one blood draw. This equals 0.2 cells identified per mL of maternal blood. If two or fewer cells are obtained, a blood redraw will be requested from the patient.	3 years
Primary	Number of fetal cells recovered and quality of DNA data on each cell	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	3 years