Cell-Based Noninvasive Prenatal Testing

NCT ID: NCT05245266

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-12

Study Completion Date

2024-03-12

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Related

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Redraw for analysis of blood samples from healthy pregnant women

Intervention Type DIAGNOSTIC_TEST

If less than two fetal cells are recovered from maternal blood, a redraw is indicated

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Pregnant
* 18 years or older
* 65 or younger

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Luna Genetics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arthur Beaudet, MD

Role: PRINCIPAL_INVESTIGATOR

Luna Genetics

Locations

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Luna Genetics

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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April O' Connor, MS, LCGC

Role: CONTACT

928-533-2429

Michelle Bellair, MSc.

Role: CONTACT

3462177049

Facility Contacts

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Arthur Beaudet, MD

Role: primary

713-202-7686

Other Identifiers

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Luna IRB LG-003

Identifier Type: -

Identifier Source: org_study_id

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