Whole Blood Specimen Collection From Healthy Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02797743|
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment|
|Healthy Volunteers||Other: Whole blood|
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.
|Study Type :||Observational|
|Estimated Enrollment :||750 participants|
|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|
Whole blood from all ages and gender
- Ages from 0 to Adults (18 yrs of age or older)
Other: Whole blood
- Whole blood collection [ Time Frame: about 3 years ]Whole blood collection from 750 healthy subjects total
Biospecimen Retention: Samples With DNA
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
|Contact: Zulema Sanchez, BAfirstname.lastname@example.org|
|Contact: Paul Bien, MSemail@example.com|
|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, Ohio, United States, 45219|
|Contact: David B. Schwartz, MD 513-241-4223|
|Study Director:||Paul Bien, MS||Head of Clinical Affairs|