Cell- Based Noninvasive Prenatal Testing (NIPT): Single Cell Prenatal Diagnosis (SCPD)

Technology Development for Noninvasive Prenatal Genetic Diagnosis Using Maternal Peripheral Blood: N o Return of Results -Luna Collection

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05076734

Acronym

NIPT & SCPD

Enrollment

157

Registered

2021-10-13

Start date

2020-06-12

Completion date

2021-12-30

Last updated

2023-03-24

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

Conditions

Pregnancy Related

Brief summary

The purpose of the overall study is to develop improved methods for recovery of fetal cells from the mother's blood in order to develop a clinically useful form of cell-based, diagnostic, noninvasive prenatal testing (NIPT). Luna Genetics will analyze 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.

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

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Pregnant * 18years or older

Exclusion criteria

* Language barrier (non-English speaking and no adequate interpreter) * Maternal age of less than 18 years * Higher order multiple pregnancy (triplet or greater) * Not currently pregnant

Design outcomes

Primary

Measure	Time frame	Description
Fetal Cell Recovery and genetic analysis	2 months	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.
Redraw for Fetal Cell Recovery and genetic analysis	2 months	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 blood.

Countries

United States

Outcome results

None listed

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