Fetal Cell Analysis From Maternal Blood

Pregnancy Related Clinical Trial

Official title:

Validation of a Cell-Based Technology for Non-Invasive-Prenatal-Diagnosis (CB-NIPD) Using Circulating Whole Fetal Cells From Maternal Peripheral Blood.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671744
• Other study ID #: MBS21-CBNIPD-001
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: September 2023

Study information

• Verified date: December 2022
• Source: Menarini Biomarkers Singapore
• Contact: Chiara Bolognesi
• Phone: +39 051 9944165
• Email: cbolognesi[@]siliconbiosystems.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genetic Disease
• Genetic Diseases, Inborn
• Pregnancy Related

Intervention

Other:
• Cell-based non-invasive prenatal testing
Blood sampling

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda-Policlinico di Milano Ospedale Maggiore	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Menarini Biomarkers Singapore

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal chromosomal abnormalities detection in circulating fetal cells,	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.	2 year
Secondary	Number of suitable fetal cells	Determination, for each participant sample, of the number of intact fetal cells recovered that are suitable for downstream analysis.	2 year
Secondary	Fetal sex assessment	Early, non-invasive fetal sex assessment	2 year