Gastrointestinal DiseasesNCT00634153
The Surgical Gastrointestinal Diseases Registry Protocol
An observational study of Gastrointestinal Diseases, run by University of Pittsburgh at 1 site in United States.
Trial summary
By placing the medical record information of many subjects into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about Gastrointestinal Diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Research Registry
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to 30 Jan 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gastrointestinal diseases.
Who may be able to join
- Subjects being seen by the University of Pittsburgh Medical Center for gastrointestinal diseases
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
About this study
By placing the medical record information of many subjects into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about Gastrointestinal Diseases.
Read the detailed description
Researchers are asking for past, current and future medical record information.
- Conditions
- Gastrointestinal Diseases
- Being tested
- Research Registry
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research RegistryOther
We are asking for permission to allow us to place subject's past, current and future medical record information into a Surgical Gastrointestinal Disease Registry. By placing the medical record information of many subjects into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about Gastrointestinal Diseases.
What is being measured
The primary outcome is the main question the study is designed to answer.
Allow researchers to review and study the medical records of many individuals to answer questions about their disease and its treatment.
Measured: 1-N/A
Secondary outcomes (1)
It will help researchers identify and recruit subjects who are eligible for participation in future research studies.
Measured: 1-N/A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startJan 2004
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Other
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall Brand, University of Pittsburgh
- Investigators
- Randall E. Brand, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634153
- Sponsor's protocol ID
- 03-145
- Status last verified
- Feb 2018
- First submitted
- 3 Mar 2008
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Surgical Gastrointestinal Diseases Registry Protocol
- ClinicalTrials.gov ID
- NCT00634153
- Acronym / sponsor ID
- 03-145
- Conditions
- Gastrointestinal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 12 Mar 2008 (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.
By placing the medical record information of many subjects into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about Gastrointestinal Diseases.
Detailed description
Researchers are asking for past, current and future medical record information.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gastrointestinal diseases.
Key inclusion criteria (1 listed)
- Subjects being seen by the University of Pittsburgh Medical Center for gastrointestinal diseases
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Research RegistryWe are asking for permission to allow us to place subject's past, current and future medical record information into a Surgical Gastrointestinal Disease Registry. By placing the medical record information of many subjects into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about Gastrointestinal Diseases. | Other | – |
Primary outcome
Allow researchers to review and study the medical records of many individuals to answer questions about their disease and its treatment.
Time frame: 1-N/A
1 secondary outcome
It will help researchers identify and recruit subjects who are eligible for participation in future research studies.
Time frame: 1-N/A
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 Feb 2018.
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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.
Randall E. Brand, MD principal investigator
University of Pittsburgh
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 Gastrointestinal Diseases, run by University of Pittsburgh 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 1 inclusion and 0 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 Feb 2018. 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.
What does the primary outcome measure?
Allow researchers to review and study the medical records of many individuals to answer questions about their disease and its treatment. (time frame: 1-N/A). 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 19 Feb 2018.