Recruiting

Prenatal Testing

Sponsor:

Luna Genetics

Code:

NCT05245266

Conditions

Pregnancy Related

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Redraw for analysis of blood samples from healthy pregnant women

Study Details

Brief summary:

The purpose of the overall study is to develop improved methods for recovery and analysis of fetal cells from the mother's blood in order to develop clinically useful forms of cell-based, diagnostic, noninvasive prenatal testing (NIPT). Luna genetics will obtain and analyze research blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood samples. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers.

Conditions

Pregnancy Related

Study ID

NCT05245266

Start date

Jan 12, 2022

Status verified date

Mar, 2023

Completion date

Mar 12, 2024

Anticipated

Primary completion date

Jan 12, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria for healthy pregnant subjects:

  • Pregnant
  • 18 years or older
  • 65 or younger

Exclusion Criteria for healthy pregnant subjects:

  • Acute illness
  • Unavailability of maternal blood sample of at least 30 ml
  • Language barrier (non-English speaking )
  • Maternal age of less than 18 years, or over 65
  • Higher order multiple pregnancy (triplet or greater)

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Analysis of blood samples from healthy pregnant women

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.

Interventions

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

Primary outcome measure

  • Number of fetal cells recovered and quality of DNA data on each cell [ Time Frame: 3 years ]
  • Number of fetal cells recovered and quality of DNA data on each cell [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

April O' Connor, MS, LCGC

928-533-2429aoconnor@lunagenetics.com

Michelle Bellair, MSc.

3462177049mbellair@lunagenetics.com

Locations

Luna Genetics

Recruiting

Houston, Texas, United States, 77054

Contacts

Arthur Beaudet, MD

713-202-7686abeaudet@lunagenetics.com

Principal Investigator:

Arthur Beaudet, MD

More Information

Sponsor

Luna Genetics

Last update posted

Mar 27, 2023

Last verified

Mar, 2023

Keywords

  • prenatal
  • genetic testing
  • noninvasive
  • diagnostic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Luna Genetics on 2023-03-27.