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OpenTrials
Completed

NCT Number: NCT03629795

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

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Key information

Conditions

Trisomy 21 in Fetus Trisomy 13 in Fetus Trisomy 18 in Fetus

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Newcastle University

Newcastle upon Tyne, UK, NE24HH, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A subject is considered eligible for participation in the trial if all of the following inclusion criteria are satisfied prior to enrolment:
  • Subject is ≥ 18 years of age
  • Subject is informed and has been given ample time and opportunity to think about her participation and has given her written informed consent.
  • 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:
  • Subject is unable to give consent
  • Subject has already participated in the study

Treatment and study plan

Primary outcomes

  1. Sample handling

    Time frame: 3 months

    Percentage change in PAPPA and BhCG levels from baseline sample type to sample type under test.

Sponsors and collaborators

Lead sponsor

Axis Shield Diagnostics Ltd

Industry

Collaborators

  • The Clinical Trial Company

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2018
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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