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

NCT ID: NCT05076734

Last Updated: 2023-03-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-12

Study Completion Date

2021-12-30

Brief Summary

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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.

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

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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

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

Countries

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United States

Other Identifiers

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Luna IRB LG-002

Identifier Type: -

Identifier Source: org_study_id

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