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Cell-Based NIPT

Cell-Based Noninvasive Prenatal Testing for Pregnancy (NIPT Trial)

N/A
Recruiting
Led By Arthur Beaudet, MD
Research Sponsored by Luna Genetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
65 or younger
Must not have
Acute illness
Recent exposure to or Active Covid-19
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve noninvasive prenatal testing by analyzing fetal cells from the blood of healthy pregnant women. Blood samples will be collected from participants across the United States, and personal identifiers will be removed to ensure privacy.

Who is the study for?
This trial is for healthy pregnant women aged between 18 and 65 in the United States. Participants must be able to provide at least a 30 ml blood sample and speak English. Women with higher order multiple pregnancies, under age 18 or over age 65, those recently exposed to or with active COVID-19, or acute illness cannot participate.
What is being tested?
The study aims to develop new methods for noninvasive prenatal testing by analyzing fetal cells from the mother's blood. Blood samples will be collected by a phlebotomist who can visit any location within the US, ensuring privacy as identifiers are removed before analysis.
What are the potential side effects?
Since this trial involves only drawing blood from participants without administering any drugs or interventions, there are minimal side effects expected beyond common blood draw reactions such as bruising or slight bleeding at the puncture site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am 65 years old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently experiencing a sudden illness.
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I currently have or recently had COVID-19.
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I am either younger than 18 or older than 65.
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I am either younger than 18 or older than 65.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of fetal cells recovered and quality of DNA data on each cell
Other study objectives
Control samples

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Analysis of blood samples from healthy pregnant womenExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Redraw for analysis of blood samples from healthy pregnant women
2020
N/A
~160

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Noninvasive prenatal testing (NIPT) involves analyzing fetal cells or cell-free fetal DNA (cffDNA) present in the maternal blood to screen for genetic conditions. The primary mechanism of action is the extraction and examination of these fetal components without the need for invasive procedures like amniocentesis or chorionic villus sampling, which carry risks of miscarriage. This matters for pregnant patients as it provides a safer, less stressful option for early detection of potential genetic abnormalities, allowing for informed decision-making and better prenatal care.
Prenatal Management of Pregnancies at Risk of Fetal Neonatal Alloimmune Thrombocytopenia (FNAIT): Scientific Impact Paper No. 61.Use of biochemical tests of placental function for improving pregnancy outcome.Maternal obesity and metabolic risk to the offspring: why lifestyle interventions may have not achieved the desired outcomes.

Find a Location

Who is running the clinical trial?

Luna GeneticsLead Sponsor
1 Previous Clinical Trials
157 Total Patients Enrolled
Arthur Beaudet, MDPrincipal InvestigatorLuna Genetics
2 Previous Clinical Trials
549 Total Patients Enrolled

Media Library

Redraw for analysis of blood samples from healthy pregnant women (Cell-Based NIPT) Clinical Trial Eligibility Overview. Trial Name: NCT05245266 — N/A
Pregnancy Clinical Trial 2023: Redraw for analysis of blood samples from healthy pregnant women Highlights & Side Effects. Trial Name: NCT05245266 — N/A
Pregnancy Research Study Groups: Analysis of blood samples from healthy pregnant women
Redraw for analysis of blood samples from healthy pregnant women (Cell-Based NIPT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05245266 — N/A
~128 spots leftby Dec 2025