HealthyNCT00926042
Genotype and Phenotype Registry: Enrollment of Normal Control Subjects for Current and Future Research
An observational study of Healthy, run by Northwell Health at 1 site in United States.
Trial summary
Registry program for volunteers who are willing to serve as control subjects in future research studies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 4,511 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Aug 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: New York City/ Long Island metropolitan community
Who may be able to join
- Generally healthy
- over age 18
Who cannot join
- under age 18
Trial locations and contacts
1 site in 1 country.
United States1 site
The Feinstein Institute for Medical Research
Manhasset, New York, 11030
About this study
Official title: TAP0307: Enrollment of Normal Control Subjects for Current and Future Research
Registry program for volunteers who are willing to serve as control subjects in future research studies.
Read the detailed description
The registry is a collection of volunteers willing to participate as control subjects in research studies. Control subjects are people who do not have a specific disease; therefore they can serve a critical role as a comparison with people who have the disease or other characteristic being studied. Once registered, participants will be notified about studies they may be able to participate in as a control.
Participation requires:
- signing a consent form
- answering a short health survey
- providing a DNA sample via a mouthwash kit
The registry allows scientists to select study participants based on whether or not they have a specific genetic change that may be relevant to a disease under investigation. Having the ability to access controls when needed is an extremely valuable resource that will speed up scientific discoveries.
- Conditions
- Healthy
- Keywords
- Healthy, volunteer, Healthy controls, Normal controls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Healthy control group for research on autoimmune diseases |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startFeb 2004
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Gregersen, Northwell Health
- Investigators
- Peter K Gregersen, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926042
- Sponsor's protocol ID
- 04-007
- Status last verified
- Sep 2016
- First submitted
- 19 Jun 2009
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: available upon application and approval
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAP0307: Enrollment of Normal Control Subjects for Current and Future Research
- ClinicalTrials.gov ID
- NCT00926042
- Acronym / sponsor ID
- 04-007
- Conditions
- Healthy
- Keywords
- Healthy, volunteer, Healthy controls, Normal controls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,511 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Jun 2009 (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.
Registry program for volunteers who are willing to serve as control subjects in future research studies.
Detailed description
The registry is a collection of volunteers willing to participate as control subjects in research studies. Control subjects are people who do not have a specific disease; therefore they can serve a critical role as a comparison with people who have the disease or other characteristic being studied. Once registered, participants will be notified about studies they may be able to participate in as a control.
Participation requires:
- signing a consent form
- answering a short health survey
- providing a DNA sample via a mouthwash kit
The registry allows scientists to select study participants based on whether or not they have a specific genetic change that may be relevant to a disease under investigation. Having the ability to access controls when needed is an extremely valuable resource that will speed up scientific discoveries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | –Healthy control group for research on autoimmune diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- New York City/ Long Island metropolitan community
Key inclusion criteria (2 listed)
- Generally healthy
- over age 18
Key exclusion criteria (1 listed)
- under age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Individual participant dataSharing planned: Yes. available upon application and approval
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 K Gregersen, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Northwell Health at 1 site 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 19 Sep 2016.