Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA Centaur PAPPA and BhCG Assays

August 13, 2018 updated by: Axis Shield Diagnostics Ltd

Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA CENTAUR® PREGNANCY ASSOCIATED PLASMA PROTEIN A and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin ASSAYS

Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.

Study Overview

Status

Completed

Conditions

Detailed Description

Blood samples are to be collected from pregnant women attending their scheduled 1st Trimester scan; the samples are to be collected immediately after the subject's routine blood sample at the clinic visit. No extra venepuncture will be required.

Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

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

Study Locations

  • United Kingdom
    • UK
      • Newcastle Upon Tyne, UK, United Kingdom, NE24HH
        • Newcastle University

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

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

First trimester pregnancy

Description

Inclusion Criteria:

  • A subject is considered eligible for participation in the trial if all of the following inclusion criteria are satisfied prior to enrolment:

    1. Subject is ≥ 18 years of age
    2. Subject is informed and has been given ample time and opportunity to think about her participation and has given her written informed consent.
    3. Women with a structurally normal viable pregnancy with a fetal crown rump length of 45-84 mm

Exclusion Criteria:

  • A subject is not eligible for participation in the trial if any of the following exclusion criteria are met prior to enrolment:

    1. Subject is unable to give consent
    2. Subject has already participated in the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sample handling
Time Frame: 3 months
Percentage change in PAPPA and BhCG levels from baseline sample type to sample type under test.
3 months

Collaborators and Investigators

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

Sponsor

Axis Shield Diagnostics Ltd

Collaborators

The Clinical Trial Company

Investigators

  • Principal Investigator: Stephen Robson, Professor of Fetal Medicine

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 17, 2017

Primary Completion (ACTUAL)

January 24, 2018

Study Completion (ACTUAL)

January 24, 2018

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (ACTUAL)

August 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TO06

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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