Fetal Cell Analysis From Maternal Blood

Not Applicable

Recruiting

• Conditions: Prenatal Screening; Genetic Disease; Pregnancy Related

• Registration Number: NCT05671744
• Lead Sponsor: Menarini Biomarkers Singapore

Brief Summary

The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-22
• Status Verified: 2022-12
• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2022-12-20
• Last Update Submitted: 2022-12-20
• Study First Posted: 2023-01-05
• Last Update Posted: 2023-01-05
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

• Participant has a viable singleton or twin pregnancy
• Women who have already been selected by their treating physician to undergo an invasive fetal diagnostic procedure
• Participant is at least 18 years old and can provide informed consent

Exclusion Criteria

• Unable to provide informed consent
• Prenatal diagnosis of clinical Chorioamnionitis
• Intake of drugs or exposure to teratogenic agents
• Infections that carry a risk of vertical transmission
• Known maternal viral diseases: HIV and HCV, HBV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Fetal chromosomal abnormalities detection in circulating fetal cells,	2 year	Evaluation of clinical performance of a cell-based technology for fetal chromosomal abnormalities detection in circulating fetal cells, using maternal blood samples from a population of high-risk pregnancies undergoing clinically indicated fetal diagnostic procedures.

Secondary Outcome Measures

Name	Time	Method
Number of suitable fetal cells	2 year	Determination, for each participant sample, of the number of intact fetal cells recovered that are suitable for downstream analysis.
Fetal sex assessment	2 year	Early, non-invasive fetal sex assessment

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda-Policlinico di Milano Ospedale Maggiore; 🇮🇹 Milan, Italy