Any Disease or ConditionNCT01717378
UCSF Research Participant Registry
An observational study of Any Disease or Condition and Healthy, run by University of California, San Francisco at 1 site in United States.
Trial summary
The UCSF Clinical and Translational Science Institute (CTSI) Consultation Service provides recruitment services and facilitates the enrollment of research participants into UCSF clinical studies. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Any Disease or Condition, Healthy
- How many people
- 1,541 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Feb 2015
- How long will I take part?
- 4 Years
- 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: General public. Anyone may join the UCSF Registry, but adult \& pediatric residents of the San Francisco Bay Area are targeted because of their proximity to UCSF research clinics.
Who may be able to join
- Adults age 18 years or older
- Minors/children with consent from parent or guardian (Parents or guardians must provide their own contact information and then complete the questionnaire using the child's health information.)
Who cannot join
- Failure to provide consent
- Minors/children without consent of parent or guardian
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical & Translational Science Institute, University of California San Francisco
San Francisco, California, 94107
About this study
Official title: Facilitating Enrollment Into UCSF Clinical Studies Via a Volunteer Research Participant Registry
The UCSF Clinical and Translational Science Institute (CTSI) Consultation Service provides recruitment services and facilitates the enrollment of research participants into UCSF clinical studies. The Recruitment Services will be accessible to all researchers at UCSF and affiliated institutions and will address the common problems that investigators encounter in the recruitment process.
Recruitment Services considered and integrated Committee on Human Research (CHR) and HIPAA regulations for ensuring human subject rights, participant privacy, and data security into the recruitment workflow and data collection/extraction methods. Recruitment Services, therefore, requests approval to implement these processes systematically for all studies that have already obtained CHR approval to begin recruitment activities.
Read the detailed description
The UCSF Research Participant Registry (http://registry.ucsf.edu) is a secure, standalone database that actively collects and stores data from willing volunteers who visit its website. The UCSF Registry is a cornerstone of the UCSF Recruitment Service (RS). Both the Registry and the RS are among several initiatives implemented by the UCSF Clinical \& Translational Science Institute.
The chief purpose of the RS is to facilitate the enrollment of research participants into UCSF clinical studies. The primary function of the Registry is to expand the pool of potential clinical research volunteers. The Registry stores self-reported identifiable health information in a searchable database that is compliant with the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA). This information is then used by the RS for the future identification and recruitment of potentially eligible participants for specific UCSF studies.
Registry participants whose data matches the major eligibility criteria for a specific study will be sent recruitment materials about the study. Contact information for the investigator or RS staff will also be included in the e-mailing. Participants are then free to choose whether to respond or ignore the study recruitment information.
- Conditions
- Any Disease or Condition, Healthy
- Keywords
- Patient Recruitment, Research Subject Recruitment, Research Subject Selection, Selection of Subjects, Health Surveys, Health Questionnaires, Health Interviews
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 |
|---|---|---|
| Potential research participants | UCSF Registry represents a single recruitment pool of individuals who have consented to be contacted about future studies for which they may be eligible based on self-reported health information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased screening & enrollment for UCSF clinical studies
By broadening the pool of potential volunteers, the Registry is expected to increase the number of screened \& enrolled participants in UCSF studies.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: This is a voluntary registry formerly managed by a unit within CTSI that was disbanded in 2013. The registry has been dormant since that time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Disease or ConditionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 1,541 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah G Grady, MD, MPH,FACP, Principal investigator, Clinical & Translational Science Institute, University of California San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717378
- Sponsor's protocol ID
- 12-08393
- Other IDs
- UL1TR000004
- Status last verified
- Mar 2015
- First submitted
- 26 Oct 2012
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Enrollment Into UCSF Clinical Studies Via a Volunteer Research Participant Registry
- ClinicalTrials.gov ID
- NCT01717378
- Acronym / sponsor ID
- 12-08393
- Conditions
- Any Disease or Condition, Healthy
- Keywords
- Patient Recruitment, Research Subject Recruitment, Research Subject Selection, Selection of Subjects, Health Surveys, Health Questionnaires, Health Interviews
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This is a voluntary registry formerly managed by a unit within CTSI that was disbanded in 2013. The registry has been dormant since that time.
- Enrolment
- 1,541 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Oct 2012 (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.
The UCSF Clinical and Translational Science Institute (CTSI) Consultation Service provides recruitment services and facilitates the enrollment of research participants into UCSF clinical studies. The Recruitment Services will be accessible to all researchers at UCSF and affiliated institutions and will address the common problems that investigators encounter in the recruitment process.
Recruitment Services considered and integrated Committee on Human Research (CHR) and HIPAA regulations for ensuring human subject rights, participant privacy, and data security into the recruitment workflow and data collection/extraction methods. Recruitment Services, therefore, requests approval to implement these processes systematically for all studies that have already obtained CHR approval to begin recruitment activities.
Detailed description
The UCSF Research Participant Registry (http://registry.ucsf.edu) is a secure, standalone database that actively collects and stores data from willing volunteers who visit its website. The UCSF Registry is a cornerstone of the UCSF Recruitment Service (RS). Both the Registry and the RS are among several initiatives implemented by the UCSF Clinical \& Translational Science Institute.
The chief purpose of the RS is to facilitate the enrollment of research participants into UCSF clinical studies. The primary function of the Registry is to expand the pool of potential clinical research volunteers. The Registry stores self-reported identifiable health information in a searchable database that is compliant with the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA). This information is then used by the RS for the future identification and recruitment of potentially eligible participants for specific UCSF studies.
Registry participants whose data matches the major eligibility criteria for a specific study will be sent recruitment materials about the study. Contact information for the investigator or RS staff will also be included in the e-mailing. Participants are then free to choose whether to respond or ignore the study recruitment information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Potential research participants | – | –UCSF Registry represents a single recruitment pool of individuals who have consented to be contacted about future studies for which they may be eligible based on self-reported health information. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General public. Anyone may join the UCSF Registry, but adult \& pediatric residents of the San Francisco Bay Area are targeted because of their proximity to UCSF research clinics.
Key inclusion criteria (2 listed)
- Adults age 18 years or older
- Minors/children with consent from parent or guardian (Parents or guardians must provide their own contact information and then complete the questionnaire using the child's health information.)
Key exclusion criteria (2 listed)
- Failure to provide consent
- Minors/children without consent of parent or guardian
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
Increased screening & enrollment for UCSF clinical studies
Time frame: 4 years
By broadening the pool of potential volunteers, the Registry is expected to increase the number of screened \& enrolled participants in UCSF studies.
Results and safety
The study was stopped early (reason given: This is a voluntary registry formerly managed by a unit within CTSI that was disbanded in 2013. The registry has been dormant since that time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- UCSF Research Participant RegistryLink provided by the sponsor.
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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.
Deborah G Grady, MD, MPH,FACP principal investigator
Clinical & Translational Science Institute, University of California San Francisco
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 Any Disease or Condition and Healthy, run by University of California, San Francisco 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 2 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: stopped early, as of the sponsor's last update on 11 Mar 2015. 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 was stopped early (reason given: This is a voluntary registry formerly managed by a unit within CTSI that was disbanded in 2013. The registry has been dormant since that time.). 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?
Increased screening & enrollment for UCSF clinical studies (time frame: 4 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 11 Mar 2015.