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Trial record 4 of 20 for:    "trisomy 13"

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

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ClinicalTrials.gov Identifier: NCT03629795
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
The Clinical Trial Company
Information provided by (Responsible Party):
Axis Shield Diagnostics Ltd

Brief Summary:
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.

Condition or disease
Trisomy 21 in Fetus Trisomy 18 in Fetus Trisomy 13 in Fetus

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.


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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : November 17, 2017
Actual Primary Completion Date : January 24, 2018
Actual Study Completion Date : January 24, 2018





Primary Outcome Measures :
  1. Sample handling [ Time Frame: 3 months ]
    Percentage change in PAPPA and BhCG levels from baseline sample type to sample type under test.


Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
First trimester pregnancy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629795


Locations
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United Kingdom
Newcastle University
Newcastle Upon Tyne, UK, United Kingdom, NE24HH
Sponsors and Collaborators
Axis Shield Diagnostics Ltd
The Clinical Trial Company
Investigators
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Principal Investigator: Stephen Robson Professor of Fetal Medicine

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Responsible Party: Axis Shield Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT03629795     History of Changes
Other Study ID Numbers: TO06
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Trisomy 13 Syndrome
Trisomy
Down Syndrome
Trisomy 18 Syndrome
Aneuploidy
Chromosome Aberrations
Pathologic Processes
Chromosome Duplication
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs