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OpenTrials
Completed

NCT Number: NCT05076734

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

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.

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Key information

Conditions

Pregnancy Related

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Luna Genetics

Houston, Texas, 77054, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Luna Genetics

Industry

Registry information

Official study title

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

Acronym: NIPT & SCPD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 13, 2021
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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