Cell-Based Noninvasive Prenatal Testing (NIPT)

March 23, 2023 updated by: Luna Genetics

Improving Methods for Cell-Based Noninvasive Prenatal Testing (NIPT)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77054
        • Recruiting
        • Luna Genetics
        • Contact:
        • Principal Investigator:
          • Arthur Beaudet, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of fetal cells recovered and quality of DNA data on each cell
Time Frame: 3 years

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

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 b
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Control samples
Time Frame: 3 years
No fetal cells should be discovered and any apparent fetal cells will be false positives.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luna Genetics

Investigators

  • Principal Investigator: Arthur Beaudet, MD, Luna Genetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2022

Primary Completion (Anticipated)

January 12, 2024

Study Completion (Anticipated)

March 12, 2024

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Luna IRB LG-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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