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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

NIPT Trial Summary

This trial is to develop improved methods for fetal cell recovery and analysis from the mother's blood, in order to create clinically useful noninvasive prenatal tests (NIPT). Luna Genetics will collect and analyze blood samples from pregnant women, healthy adult males, and non-pregnant females. Control samples will be collected from healthy adult males and non-pregnant females.

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.Check my eligibility
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.See study design
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.

NIPT Trial 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.
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My overall health is good.
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I am 65 years old or younger.
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I am 65 years old or younger.
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I am 18 years old or older.
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I am 18 years old or older.

NIPT Trial 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

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

NIPT 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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment open at the present?

"Yes, clinicaltrials.gov confirms that this medical study is currently recruiting participants and opened for enrollment on the 12th of January 2022. The trial was last modified on 16th February 2022, with 500 patients being recruited from a single site."

Answered by AI

Can participants aged 35 and younger apply for this medical study?

"To be eligible, patients must between 18 and 65 years of age. For those under the legal consenting age (18) there are 24 trials open for enrollment; for senior citizens (over 65), 87 studies currently have patient recruitment underway."

Answered by AI

What is the current enrollment count for this experiment?

"Yes, the research is currently being conducted according to the information posted on clinicaltrials.gov; it was first advertised in December of 2022 and has recently been updated as of February 16th 2022. This trial needs 500 people from a single location."

Answered by AI

Am I able to participate in this investigation?

"To qualify, potential participants must be of childbearing age and between 18-65 years old. This clinical trial is seeking to enrol 500 people in total."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Luna Genetics
What portion of applicants met pre-screening criteria?
Met criteria
~158 spots leftby Mar 2025