NCT05671744RecruitingNot Applicable
Validation of a Cell-Based Technology for Non-Invasive-Prenatal-Diagnosis (CB-NIPD) Using Circulating Whole Fetal Cells From Maternal Peripheral Blood.
Menarini Biomarkers Singapore1 site in 1 country1,500 target enrollmentStarted: November 22, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- Fetal chromosomal abnormalities detection in circulating fetal cells,
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of suitable fetal cells(2 year)
- Fetal sex assessment(2 year)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Development and Validation of an Noninvasive Model for Predicting High Risk Esophageal Varices in CirrhosisEsophageal and Gastric VaricesNCT04210297Qilu Hospital of Shandong University245
Completed
Not Applicable
Cell Based Non Invasive Prenatal Testing as an Alternative to Chorionic Villus Sampling Following Preimplantation Genetic TestingPrenatal DiagnosesPreimplantation Genetic DiagnosisNCT04584047Aalborg University Hospital8
Completed
Not Applicable
Clinical Validation of Continuous and Non-invasive Monitoring of Effective Pulmonary Volume.Critical IllnessNCT04045262Fernando Suarez Sipmann85
Completed
Not Applicable
Research on clinical application of non-invasive triglyceride measuring deviceHyperlipidemiaJPRN-UMIN000044544Takasaki University of Health and Welfare51
Unknown
Not Applicable
Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic MembranesIntra-amniotic InfectionNCT00700219ProteoGenix, Inc.900