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

Not Applicable

Completed

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

• Registration Number: NCT05076734
• Lead Sponsor: Luna Genetics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-12
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-10-13
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 157

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

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	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
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.

Trial Locations

Locations (1)

Luna Genetics; 🇺🇸 Houston, Texas, United States