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

Trisomy 21 in Fetus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629795
• Other study ID #: TO06
• Status: Completed
• Start date: November 17, 2017
• Est. completion date: January 24, 2018

Study information

• Verified date: August 2018
• Source: Axis Shield Diagnostics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 24, 2018
• Est. primary completion date: January 24, 2018
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Trisomy 13 in Fetus
• Trisomy 18 in Fetus
• Trisomy 21 in Fetus

Locations

Country	Name	City	State
United Kingdom	Newcastle University	Newcastle Upon Tyne	UK

Sponsors (2)

Lead Sponsor	Collaborator
Axis Shield Diagnostics Ltd	The Clinical Trial Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sample handling	Percentage change in PAPPA and BhCG levels from baseline sample type to sample type under test.	3 months