Prenatal ScreeningNCT05671744
Fetal Cell Analysis From Maternal Blood
A study testing Cell-based non-invasive prenatal testing in people with Prenatal Screening and Pregnancy Related, run by Menarini Biomarkers Singapore at 1 site in Italy.
Trial summary
The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prenatal Screening, Pregnancy Related, Genetic Disease
- What is being tested?
- Cell-based non-invasive prenatal testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 22 Nov 2021to Sep 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has a viable singleton or twin pregnancy
- Women who have already been selected by their treating physician to undergo an invasive fetal diagnostic procedure
- Participant is at least 18 years old and can provide informed consent
Who cannot join
- Unable to provide informed consent
- Prenatal diagnosis of clinical Chorioamnionitis
- Intake of drugs or exposure to teratogenic agents
- Infections that carry a risk of vertical transmission
- Known maternal viral diseases: HIV and HCV, HBV
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda-Policlinico di Milano Ospedale Maggiore
Milan
Enrico Ferrazzi, Prof.
About this study
Official title: Validation of a Cell-Based Technology for Non-Invasive-Prenatal-Diagnosis (CB-NIPD) Using Circulating Whole Fetal Cells From Maternal Peripheral Blood.
The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.
- Conditions
- Prenatal Screening, Pregnancy Related, Genetic Disease
- Being tested
- Cell-based non-invasive prenatal testing
- Medical subject headings
- Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell-based non-invasive prenatal testingOther
Blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Blood samples from pregnant women | Other | Samples of peripheral blood collected from pregnant women undergoing CVS or genetic amniocentesis Receives: Other: Cell-based non-invasive prenatal testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal chromosomal abnormalities detection in circulating fetal cells,
Evaluation of clinical performance of a cell-based technology for fetal chromosomal abnormalities detection in circulating fetal cells, using maternal blood samples from a population of high-risk pregnancies undergoing clinically indicated fetal diagnostic procedures.
Measured: 2 year
Secondary outcomes (2)
Number of suitable fetal cells
Determination, for each participant sample, of the number of intact fetal cells recovered that are suitable for downstream analysis.
Measured: 2 year
Fetal sex assessment
Early, non-invasive fetal sex assessment
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start22 Nov 2021
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal ScreeningStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menarini Biomarkers Singapore
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671744
- Sponsor's protocol ID
- MBS21-CBNIPD-001
- Status last verified
- Dec 2022
- First submitted
- 20 Dec 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Cell-Based Technology for Non-Invasive-Prenatal-Diagnosis (CB-NIPD) Using Circulating Whole Fetal Cells From Maternal Peripheral Blood.
- ClinicalTrials.gov ID
- NCT05671744
- Acronym / sponsor ID
- MBS21-CBNIPD-001
- Conditions
- Prenatal Screening, Pregnancy Related, Genetic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Menarini Biomarkers SingaporeIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 5 Jan 2023 (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 aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood samples from pregnant women | Other | Other: Cell-based non-invasive prenatal testingSamples of peripheral blood collected from pregnant women undergoing CVS or genetic amniocentesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant has a viable singleton or twin pregnancy
- Women who have already been selected by their treating physician to undergo an invasive fetal diagnostic procedure
- Participant is at least 18 years old and can provide informed consent
Key exclusion criteria (5 listed)
- Unable to provide informed consent
- Prenatal diagnosis of clinical Chorioamnionitis
- Intake of drugs or exposure to teratogenic agents
- Infections that carry a risk of vertical transmission
- Known maternal viral diseases: HIV and HCV, HBV
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 |
|---|---|---|
| Cell-based non-invasive prenatal testingBlood sampling | Other | Blood samples from pregnant women |
Primary outcome
Fetal chromosomal abnormalities detection in circulating fetal cells,
Time frame: 2 year
Evaluation of clinical performance of a cell-based technology for fetal chromosomal abnormalities detection in circulating fetal cells, using maternal blood samples from a population of high-risk pregnancies undergoing clinically indicated fetal diagnostic procedures.
2 secondary outcomes
Number of suitable fetal cells
Time frame: 2 year
Fetal sex assessment
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell-based non-invasive prenatal testing in people with Prenatal Screening and Pregnancy Related, run by Menarini Biomarkers Singapore at 1 site in Italy.
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 5 Jan 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 Italy. 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 Chiara Bolognesi (+39 051 9944165, cbolognesi@siliconbiosystems.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal chromosomal abnormalities detection in circulating fetal cells, (time frame: 2 year). 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 5 Jan 2023.