Fetal Cell Analysis From Maternal Blood

December 20, 2022 updated by: Menarini Biomarkers Singapore

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Ca' Granda-Policlinico di Milano Ospedale Maggiore
        • Contact:
          • Enrico Ferrazzi, Prof.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Blood samples from pregnant women
Samples of peripheral blood collected from pregnant women undergoing CVS or genetic amniocentesis
Other: Cell-based non-invasive prenatal testing
Blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal chromosomal abnormalities detection in circulating fetal cells,
Time Frame: 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.
2 year

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Menarini Biomarkers Singapore

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 (Actual)

November 22, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

December 20, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBS21-CBNIPD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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