Clincosm LogoSign in Get a demo

Fetal Cell Analysis From Maternal Blood

Sponsor
Menarini Biomarkers Singapore (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05671744
Collaborator
(none)
1,500
Enrollment
1
Location
1
Arm
21.3
Anticipated Duration (Months)
70.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cell-based non-invasive prenatal testing
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Validation of a Cell-Based Technology for Non-Invasive-Prenatal-Diagnosis (CB-NIPD) Using Circulating Whole Fetal Cells From Maternal Peripheral Blood.
Actual Study Start Date :
Nov 22, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Fetal chromosomal abnormalities detection in circulating fetal cells, [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 Outcome Measures

  1. Number of suitable fetal cells [2 year]

    Determination, for each participant sample, of the number of intact fetal cells recovered that are suitable for downstream analysis.

  2. Fetal sex assessment [2 year]

    Early, non-invasive fetal sex assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondazione IRCCS Ca' Granda-Policlinico di Milano Ospedale Maggiore Milan Italy

Sponsors and Collaborators

  • Menarini Biomarkers Singapore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Menarini Biomarkers Singapore
ClinicalTrials.gov Identifier:
NCT05671744
Other Study ID Numbers:
  • MBS21-CBNIPD-001
First Posted:
Jan 5, 2023
Last Update Posted:
Jan 5, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Genetic Diseases, Inborn

Study Results

No Results Posted as of Jan 5, 2023