Pregnancy RelatedNIPTNCT05245266
Cell-Based Noninvasive Prenatal Testing
A study testing Redraw for analysis of blood samples from healthy pregnant women in people with Pregnancy Related, run by Luna Genetics at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Redraw for analysis of blood samples from healthy pregnant women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2022to 12 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant
- 18 years or older
- 65 or younger
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Luna Genetics
Houston, Texas, 77054
Arthur Beaudet, MD, 713-202-7686, abeaudet@lunagenetics.com
Arthur Beaudet, MD
About this study
Official title: Improving Methods for Cell-Based Noninvasive Prenatal Testing (NIPT)
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.
- Conditions
- Pregnancy Related
- Being tested
- Redraw for analysis of blood samples from healthy pregnant women
- Keywords
- prenatal, genetic testing, noninvasive, diagnostic
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Redraw for analysis of blood samples from healthy pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start12 Jan 2022
- Primary completion12 Jan 2024 (estimated)
- Study completion12 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luna Genetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur Beaudet, MD, Principal investigator, Luna Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245266
- Sponsor's protocol ID
- Luna IRB LG-003
- Acronym
- NIPT
- Status last verified
- Mar 2023
- First submitted
- 3 Feb 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Methods for Cell-Based Noninvasive Prenatal Testing (NIPT)
- ClinicalTrials.gov ID
- NCT05245266
- Acronym / sponsor ID
- NIPT / Luna IRB LG-003
- Conditions
- Pregnancy Related
- Keywords
- prenatal, genetic testing, noninvasive, diagnostic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Luna GeneticsIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 12 Jan 2024 (estimated)
- Study completion
- 12 Mar 2024 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Analysis of blood samples from healthy pregnant women | Other | Diagnostic Test: Redraw for analysis of blood samples from healthy pregnant womenAnalysis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant
- 18 years or older
- 65 or younger
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Redraw for analysis of blood samples from healthy pregnant womenIf less than two fetal cells are recovered from maternal blood, a redraw is indicated | Diagnostic test | Analysis of blood samples from healthy pregnant women |
Primary outcome
Number of fetal cells recovered and quality of DNA data on each cell
Time frame: 3 years
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.
Number of fetal cells recovered and quality of DNA data on each cell
Time frame: 3 years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Beaudet, MD principal investigator
Luna Genetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Redraw for analysis of blood samples from healthy pregnant women in people with Pregnancy Related, run by Luna Genetics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact April O' Connor, MS, LCGC (928-533-2429, aoconnor@lunagenetics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of fetal cells recovered and quality of DNA data on each cell (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.