Cell-Based Noninvasive Prenatal Testing

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05245266

Acronym

NIPT

Enrollment

500

Registered

2022-02-17

Start date

2022-01-12

Completion date

2024-03-12

Last updated

2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related

Keywords

prenatal, genetic testing, noninvasive, diagnostic

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.

Interventions

DIAGNOSTIC_TESTRedraw for analysis of blood samples from healthy pregnant women

If less than two fetal cells are recovered from maternal blood, a redraw is indicated

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of fetal cells recovered and quality of DNA data on each cell	3 years	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.

Countries

United States

Contacts

Primary ContactApril O' Connor, MS, LCGC

aoconnor@lunagenetics.com928-533-2429

Backup ContactMichelle Bellair, MSc.

mbellair@lunagenetics.com3462177049

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026