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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2022

Interventions

  • 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

Arms, Groups and Cohorts

  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Fetal Cell Recovery and genetic analysis
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Pregnant – 18years or older Exclusion Criteria:

  • Unavailability of maternal blood sample of at least 30 ml – Language barrier (non-English or Spanish speaking and no adequate interpreter) – Maternal age of less than 18 years – Higher order multiple pregnancy (triplet or greater) – Recent exposure to or Active Covid-19

Gender Eligibility: Female

Females, 18 years and older

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Luna Genetics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Arthur Beaudet, MD, Principal Investigator, Luna Genetics
  • Overall Contact(s)
    • April O’ Connor, MS, LCGC, 928-533-2429, aoconnor@lunagenetics.com

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