NCT05245266

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2024

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

February 3, 2022

Last Update Submit

March 23, 2023

Conditions

Pregnancy Related

Keywords

prenatalgenetic testingnoninvasivediagnostic

Outcome Measures

Primary Outcomes (2)

  • Number of fetal cells recovered and quality of DNA data on each cell

    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

    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

Study Arms (1)

Analysis of blood samples from healthy pregnant women

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.

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

Interventions

Redraw for analysis of blood samples from healthy pregnant womenDIAGNOSTIC_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

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll healthy pregnant female volunteers.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant
  • years or older
  • or younger

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luna Genetics

Houston, Texas, 77054, United States

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arthur Beaudet, MD

    Luna Genetics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

April O' Connor, MS, LCGC

CONTACT

928-533-2429aoconnor@lunagenetics.com

Michelle Bellair, MSc.

CONTACT

3462177049mbellair@lunagenetics.com

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

February 3, 2022

First Posted

February 17, 2022

Study Start

January 12, 2022

Primary Completion

January 12, 2024

Study Completion

March 12, 2024

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

US(1)