Pancreatic CancerSPORENCT00584363
Pancreatic and Gastrointestinal Tumor Registry and Tissue Collection
An observational study of Pancreatic Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to collect pancreatic tissue, blood and urine from adults to study pancreatic abnormalities. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 731 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Sep 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults 19 years of age or older, pancreatic cancer patients at the University of Alabam at Birmingham.
Who may be able to join
- Person over 19 years of age, patient with a tissue-proven diagnosis of pancreatic cancer at the University of Alabama at Birmingham (UAB) University Hospital during the period, and cognitive ability to provide informed consent
Who cannot join
- Person not 19 or older and have not had a tissue-proven diagnosis of pancreatic cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Pancreatic and Gastrointestinal Tumor Registry and Tissue Collection (UAB/UMN SPORE in Pancreatic Cancer)
The purpose of the study is to collect pancreatic tissue, blood and urine from adults to study pancreatic abnormalities.
Read the detailed description
The aim of the study is to standardize, collect and share pancreatic cancer related information, to be used for research purposes only by researchers from different participating institutions/centers.
- Conditions
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To diagnose Pancreatic Cancer
Measured: 5 years
Secondary outcomes (1)
Preventing patient form being misdiagnosed
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startJun 2004
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Charles Mel Wilcox, MD, University of Alabama at Birmingham
- Investigators
- Charles M Wilcox, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584363
- Sponsor's protocol ID
- F040514008
- Other IDs
- 2P50CA101955
- Acronym
- SPORE
- Status last verified
- Oct 2017
- First submitted
- 24 Dec 2007
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic and Gastrointestinal Tumor Registry and Tissue Collection (UAB/UMN SPORE in Pancreatic Cancer)
- ClinicalTrials.gov ID
- NCT00584363
- Acronym / sponsor ID
- SPORE / F040514008
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2004
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 2 Jan 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.
The purpose of the study is to collect pancreatic tissue, blood and urine from adults to study pancreatic abnormalities.
Detailed description
The aim of the study is to standardize, collect and share pancreatic cancer related information, to be used for research purposes only by researchers from different participating institutions/centers.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 19 years of age or older, pancreatic cancer patients at the University of Alabam at Birmingham.
Key inclusion criteria (1 listed)
- Person over 19 years of age, patient with a tissue-proven diagnosis of pancreatic cancer at the University of Alabama at Birmingham (UAB) University Hospital during the period, and cognitive ability to provide informed consent
Key exclusion criteria (1 listed)
- Person not 19 or older and have not had a tissue-proven diagnosis of pancreatic cancer.
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
To diagnose Pancreatic Cancer
Time frame: 5 years
1 secondary outcome
Preventing patient form being misdiagnosed
Time frame: 5 years
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 5 Oct 2017.
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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.
Charles M Wilcox, MD principal investigator
University of Alabama at Birmingham
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 Pancreatic Cancer, run by University of Alabama at Birmingham 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 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 5 Oct 2017. 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?
To diagnose Pancreatic Cancer (time frame: 5 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 5 Oct 2017.