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.

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Key information

Conditions

Pregnant Women

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Unable to provide informed consent
Known infections that carry a risk of vertical transmission
Known maternal viral diseases: HIV and HCV, HBV

Treatment and study plan

Blood collection

Other

Samples of peripheral blood (30 ml) will be collected from pregnant women

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Menarini Silicon Biosystems

Industry

Registry information

Official study title

Prospective Collection of Maternal Venous Blood Samples for Cell-based Non- Invasive Prenatal Test Workflow

Acronym: TOTAL#5

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 5, 2026
Registry last updated: May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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