NCT03629795

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

July 26, 2018

Last Update Submit

August 13, 2018

Conditions

Trisomy 21 in FetusTrisomy 18 in FetusTrisomy 13 in Fetus

Outcome Measures

Primary Outcomes (1)

  • Sample handling

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

    3 months

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

First trimester pregnancy

You may qualify if:

  • 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

You may not qualify if:

  • Subject is unable to give consent
  • Subject has already participated in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newcastle University

Newcastle upon Tyne, UK, NE24HH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Officials

  • Stephen Robson

    Professor of Fetal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2018

First Posted

August 14, 2018

Study Start

November 17, 2017

Primary Completion

January 24, 2018

Study Completion

January 24, 2018

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)