NCT02797743

Brief Summary

This study will obtain whole blood specimens from healthy subjects to be used for research and development and clinical validation of genetic assays.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

July 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

6 years

First QC Date

May 25, 2016

Last Update Submit

September 15, 2020

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Whole blood collection

    Whole blood collection from 750 healthy subjects total

    about 3 years

Study Arms (1)

Whole blood from all ages and gender

\- Ages from 0 to Adults (18 yrs of age or older)

Other: Whole blood

Interventions

Whole bloodOTHER

* Adults ≥18 yrs of age: up to 50 mL (5 tubes) * Adolescents 12-17 yrs of age: up to 30 mL (3 tubes) * Children 0-11 yrs of age: single tube (1 tube, 10 mL)

Whole blood from all ages and gender

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men, pregnant women or children, no age restrictions.

You may qualify if:

  • Subject (or guardian)is willing to provide written informed consent to have up to 50 mL of whole blood collected at a single clinic visit (maximum blood volume will depend on age of subject)
  • Subject is considered healthy (and if pregnant, their pregnancy is progressing normally)
  • If pregnant, Subject is carrying a singleton fetus of 10 to 26 weeks' gestational age inclusive

You may not qualify if:

  • Women who are not pregnant
  • If pregnant, pregnancy is non-viable
  • If pregnant, evidence of or suspected fetal anomaly based on ultrasound finding, abnormal 1st trimester screening or abnormal NIPT
  • Immediate family history of a previous fetal aneuploidy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Heinen Obstetrics & Gynecology

Eunice, Louisiana, 70535, United States

Location

Virtua Medical Group

Voorhees Township, New Jersey, 08043, United States

Location

Cincinnati Obgyn

Cincinnati, Ohio, 45219, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples

Study Officials

  • Peter Stiegler, PhD

    Head of Clinical Affairs

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 25, 2016

First Posted

June 13, 2016

Study Start

July 1, 2015

Primary Completion

July 1, 2021

Study Completion

September 1, 2021

Last Updated

September 17, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)