Pregnant WomenTOTAL#5NCT07566780
Cell-based Non-invasive Prenatal Test Workflow
An observational study of Pregnant Women, run by Menarini Silicon Biosystems.
Trial summary
The aim of this study is to optimize a new non-invasive prenatal screening method based on the capture of fetal cells from maternal blood and to complete its development by obtaining maternal blood samples during the first trimester of pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Blood collection
- How many people
- 1,400 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Samples of peripheral blood (30 ml) will be collected from pregnant women at 8+0 - 14+6 weeks of gestation.
Who may be able to join
- Informed consent signed before any study-specific procedures
- Pregnant women with singleton or twin pregnancy, at 8+0 - 14+6 week of gestation, aged ≥18 years
- No medical contraindication for collecting 30 ml blood sample
Who cannot join
- Unable to provide informed consent
- Known infections that carry a risk of vertical transmission
- Known maternal viral diseases: HIV and HCV, HBV
About this study
Official title: Prospective Collection of Maternal Venous Blood Samples for Cell-based Non- Invasive Prenatal Test Workflow
The aim of this study is to optimize a new non-invasive prenatal screening method based on the capture of fetal cells from maternal blood and to complete its development by obtaining maternal blood samples during the first trimester of pregnancy.
- Conditions
- Pregnant Women
- Being tested
- Blood collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
Samples of peripheral blood (30 ml) will be collected from pregnant women
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Not described Receives: Other: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
cEVTs isolation rate
To achieve a minimum recovery of 3 single fetal cells in at least 95% of 30mL maternal blood samples
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start4 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menarini Silicon Biosystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566780
- Sponsor's protocol ID
- MSB25-CBNIPT-001
- Acronym
- TOTAL#5
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 5 May 2026
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Maternal Venous Blood Samples for Cell-based Non- Invasive Prenatal Test Workflow
- ClinicalTrials.gov ID
- NCT07566780
- Acronym / sponsor ID
- TOTAL#5 / MSB25-CBNIPT-001
- Conditions
- Pregnant Women
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Menarini Silicon BiosystemsIndustry (pharma, biotech, devices)
- Study start
- 4 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 May 2026 (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 study is to optimize a new non-invasive prenatal screening method based on the capture of fetal cells from maternal blood and to complete its development by obtaining maternal blood samples during the first trimester of pregnancy.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: Blood collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Samples of peripheral blood (30 ml) will be collected from pregnant women at 8+0 - 14+6 weeks of gestation.
Key inclusion criteria (3 listed)
- Informed consent signed before any study-specific procedures
- Pregnant women with singleton or twin pregnancy, at 8+0 - 14+6 week of gestation, aged ≥18 years
- No medical contraindication for collecting 30 ml blood sample
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Known 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 |
|---|---|---|
| Blood collectionSamples of peripheral blood (30 ml) will be collected from pregnant women | Other | Pregnant women |
Primary outcome
cEVTs isolation rate
Time frame: 24 months
To achieve a minimum recovery of 3 single fetal cells in at least 95% of 30mL maternal blood samples
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women, run by Menarini Silicon Biosystems.
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 3 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: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cEVTs isolation rate (time frame: 24 months). 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 May 2026.