Healthy VolunteersNCT02797743
Whole Blood Specimen Collection From Healthy Subjects
An observational study of Healthy Volunteers, run by Progenity, Inc. at 3 sites in United States.
Trial summary
This study will obtain whole blood specimens from healthy subjects to be used for research and development and clinical validation of genetic assays. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Whole blood
- How many people
- 750 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2015to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Men, pregnant women or children, no age restrictions.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Obgyn
Cincinnati, Ohio, 45219
Heinen Obstetrics & Gynecology
Eunice, Louisiana, 70535
Virtua Medical Group
Voorhees Township, New Jersey, 08043
About this study
This study will obtain whole blood specimens from healthy subjects to be used for research and development and clinical validation of genetic assays.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Whole blood
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Whole blood from all ages and gender | - Ages from 0 to Adults (18 yrs of age or older) Receives: Other: Whole blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole blood collection
Whole blood collection from 750 healthy subjects total
Measured: about 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progenity, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Stiegler, PhD, Study director, Head of Clinical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797743
- Sponsor's protocol ID
- PRO-111-HEALTHY
- Status last verified
- Sep 2020
- First submitted
- 25 May 2016
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Blood Specimen Collection From Healthy Subjects
- ClinicalTrials.gov ID
- NCT02797743
- Acronym / sponsor ID
- PRO-111-HEALTHY
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Progenity, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will obtain whole blood specimens from healthy subjects to be used for research and development and clinical validation of genetic assays.
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole blood from all ages and gender | – | Other: Whole blood- Ages from 0 to Adults (18 yrs of age or older) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men, pregnant women or children, no age restrictions.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | Whole blood from all ages and gender |
Primary outcome
Whole blood collection
Time frame: about 3 years
Whole blood collection from 750 healthy subjects total
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Stiegler, PhD study director
Head of Clinical Affairs
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Progenity, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole blood collection (time frame: about 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.