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

NCT05076734 | Completed

• 1 other identifier: Luna IRB LG-002
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• Fetal Cell Recovery and genetic analysis

  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.

  2 months

• Redraw for Fetal Cell Recovery and genetic analysis

  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.

  2 months

Study Arms (1)

Analysis of blood samples from healthy pregnant women

OTHER

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.

Diagnostic Test: Redraw for analysis of blood samples from healthy pregnant women

Interventions

Redraw for analysis of blood samples from healthy pregnant women DIAGNOSTIC_TEST

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

Analysis of blood samples from healthy pregnant women

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Females, 18 years and older
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Luna Genetics: lead

Study Sites (1)

Luna Genetics

Houston, Texas, 77054, United States

Location

Study Officials

• Arthur Beaudet, MD

  Luna Genetics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 13, 2021
• Study Start: June 12, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

US (1)