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Whole Blood Specimen Collection From Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02797743
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Progenity, Inc.

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.

Condition or disease Intervention/treatment
Healthy Volunteers Other: Whole blood

Detailed Description:

Progenity is developing diagnostic products to improve the healthcare of men, women, and children. The commercial objective is to make safe, noninvasive genetic testing available to the public, independent of age and other factors that may contribute to pregnancy or other clinical complications.

Sample specimens will not be used to develop genetic lines and/or DNA banks for cloning. Any samples or remnant specimens remaining may be stored indefinitely for future research programs.

Eligible subjects (or parent/guardian) will provide written informed consent after which basic demographic and clinical data will be obtained and a whole blood sample will be collected. A subject's participation may end immediately after their blood draw. The amount of whole blood drawn at any visit will be based upon age of the subject and test to be performed.

In the event a Subject is pregnant, information regarding the gender of the fetus established by either ultrasound, non-invasive prenatal testing (NIPT) results, or at delivery will be collected. Clinical data regarding any karyotyping procedure that may occur on the fetus will be recorded.


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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Whole Blood Specimen Collection From Healthy Subjects
Actual Study Start Date : July 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Group/Cohort Intervention/treatment
Whole blood from all ages and gender
- Ages from 0 to Adults (18 yrs of age or older)
Other: Whole blood
  • 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)




Primary Outcome Measures :
  1. Whole blood collection [ Time Frame: about 3 years ]
    Whole blood collection from 750 healthy subjects total


Biospecimen Retention:   Samples With DNA
Whole blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men, pregnant women or children, no age restrictions.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT02797743


Contacts
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Contact: Zulema Sanchez, BA 760-494-1742 zulema.sanchez@progenity.com
Contact: Paul Bien, MS 760-494-1743 paul.bien@progenity.com

Locations
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United States, Louisiana
Heinen Obstetrics & Gynecology Recruiting
Eunice, Louisiana, United States, 70535
Contact: Monty Heinan, MD    337-546-6237      
United States, New Jersey
Virtua Medical Group Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Ronald J. Librizzi, DO    856-247-3328      
United States, Ohio
Cincinnati Obgyn Recruiting
Cincinnati, Ohio, United States, 45219
Contact: David B. Schwartz, MD    513-241-4223      
Sponsors and Collaborators
Progenity, Inc.
Investigators
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Study Director: Paul Bien, MS Head of Clinical Affairs

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Responsible Party: Progenity, Inc.
ClinicalTrials.gov Identifier: NCT02797743     History of Changes
Other Study ID Numbers: PRO-111-HEALTHY
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Progenity, Inc.:
Healthy Volunteers