Cell-based Non-invasive Prenatal Test Workflow

N/ANot Yet RecruitingNCT07566780

Menarini Silicon Biosystems1,400 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,400

Conditions

Pregnant Women

Interventions

Blood collectionOTHER

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

cEVTs isolation rate

To achieve a minimum recovery of 3 single fetal cells in at least 95% of 30mL maternal blood samples

Time frame: 24 months

Data from ClinicalTrials.gov

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