Cell-based Non-invasive Prenatal Test Workflow

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07566780

Acronym

TOTAL#5

Enrollment

1400

Registered

2026-05-05

Start date

2026-05-04

Completion date

2027-12-31

Last updated

2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant Women

Brief 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.

Interventions

OTHERBlood collection

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

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Informed consent signed before any study-specific procedures 2. Pregnant women with singleton or twin pregnancy, at 8+0 - 14+6 week of gestation, aged ≥18 years 3. No medical contraindication for collecting 30 ml blood sample

Exclusion criteria

1. Unable to provide informed consent 2. Known infections that carry a risk of vertical transmission 3. Known maternal viral diseases: HIV and HCV, HBV

Design outcomes

Primary

Measure	Time frame	Description
cEVTs isolation rate	24 months	To achieve a minimum recovery of 3 single fetal cells in at least 95% of 30mL maternal blood samples

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026