Cell-based Non-invasive Prenatal Test Workflow (TOTAL#5)

April 28, 2026 updated by: Menarini Silicon Biosystems

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Samples of peripheral blood (30 ml) will be collected from pregnant women at 8+0 - 14+6 weeks of gestation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women
Other: Blood collection
Samples of peripheral blood (30 ml) will be collected from pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menarini Silicon Biosystems

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 4, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSB25-CBNIPT-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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