Back to resultsFetal Cell Analysis From Maternal Blood
Primary Purpose
Prenatal Screening, Pregnancy Related, Genetic Disease
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cell-based non-invasive prenatal testing
Sponsored by
About this trial
This is an interventional screening trial for Prenatal Screening
Eligibility Criteria
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
Sites / Locations
- Fondazione IRCCS Ca' Granda-Policlinico di Milano Ospedale MaggioreRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Blood samples from pregnant women
Arm Description
Samples of peripheral blood collected from pregnant women undergoing CVS or genetic amniocentesis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of suitable fetal cells
Determination, for each participant sample, of the number of intact fetal cells recovered that are suitable for downstream analysis.
Fetal sex assessment
Early, non-invasive fetal sex assessment
Full Information
NCT ID
NCT05671744
First Posted
December 20, 2022
Last Updated
December 20, 2022
Sponsor
Menarini Biomarkers Singapore
1. Study Identification
Unique Protocol Identification Number
NCT05671744
Brief Title
Fetal Cell Analysis From Maternal Blood
Official Title
Validation of a Cell-Based Technology for Non-Invasive-Prenatal-Diagnosis (CB-NIPD) Using Circulating Whole Fetal Cells From Maternal Peripheral Blood.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menarini Biomarkers Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prenatal Screening, Pregnancy Related, Genetic Disease
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blood samples from pregnant women
Arm Type
Other
Arm Description
Samples of peripheral blood collected from pregnant women undergoing CVS or genetic amniocentesis
Intervention Type
Other
Intervention Name(s)
Cell-based non-invasive prenatal testing
Intervention Description
Blood sampling
Primary Outcome Measure Information:
Title
Fetal chromosomal abnormalities detection in circulating fetal cells,
Description
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.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Number of suitable fetal cells
Description
Determination, for each participant sample, of the number of intact fetal cells recovered that are suitable for downstream analysis.
Time Frame
2 year
Title
Fetal sex assessment
Description
Early, non-invasive fetal sex assessment
Time Frame
2 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chiara Bolognesi
Phone
+39 051 9944165
Email
cbolognesi@siliconbiosystems.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Doffini
Phone
+39 051 9944253
Email
anna.doffini@mbiomarkers.com
Facility Information:
Facility Name
Fondazione IRCCS Ca' Granda-Policlinico di Milano Ospedale Maggiore
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrico Ferrazzi, Prof.
12. IPD Sharing Statement
Plan to Share IPD
No
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Fetal Cell Analysis From Maternal Blood
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