Fetal Cell Analysis From Maternal Blood
Validation of a Cell-Based Technology for Non-Invasive-Prenatal-Diagnosis (CB-NIPD) Using Circulating Whole Fetal Cells From Maternal Peripheral Blood.
1 other identifier
interventional
1,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 22, 2021
CompletedFirst Submitted
Initial submission to the registry
December 20, 2022
CompletedFirst Posted
Study publicly available on registry
January 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedJanuary 5, 2023
December 1, 2022
1.8 years
December 20, 2022
December 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of suitable fetal cells
2 year
Fetal sex assessment
2 year
Study Arms (1)
Blood samples from pregnant women
OTHERSamples of peripheral blood collected from pregnant women undergoing CVS or genetic amniocentesis
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione IRCCS Ca' Granda-Policlinico di Milano Ospedale Maggiore
Milan, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2022
First Posted
January 5, 2023
Study Start
November 22, 2021
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
January 5, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share