Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 27, 2009 | ||||
| Last Updated Date | January 11, 2013 | ||||
| Start Date ICMJE | October 2000 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE |
|
||||
| Change History | Complete list of historical versions of study NCT00830557 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders | ||||
| Official Title ICMJE | Biospecimen Resource for Pancreas Research, a Data & Tissue Bank (Also Known as a Bio-repository, Bio-bank, Data & Tissue Database, Data & Tissue Registry, Etc.) to Help Advance Research in Pancreas Disease | ||||
| Brief Summary | RATIONALE: Gathering medical information and collecting and storing samples of blood and tissue to test in the laboratory may help doctors develop better ways to screen people at risk for pancreatic cancer or other pancreatic disorders in the future. PURPOSE: This clinical trial is collecting medical information and tissue samples from patients with pancreatic cancer or other pancreatic disorders. |
||||
| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients complete two 1-hour surveys assessing health, clinical and family history of pancreatic conditions including cancer, and food preparation and intake. Patients also complete a 15- to 30-minute follow up survey at 6 months and 1 year to assess health, health practices, and family history. A review of the patient's medical information is obtained from the medical record. Blood samples are collected for future research studies. Oral cells and stool samples may also be collected for future studies. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Two 10mL plasma tubes, two 10mL serum tubes and one 10mL heparin tube collected. DNA extracted from lymphocytes. Possible saliva collection for DNA extraction. Waste tissue from prior surgery may be collected. Stool samples may be collected. |
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Pancreas disease patients |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 7500 | ||||
| Estimated Completion Date | August 2014 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00830557 | ||||
| Other Study ID Numbers ICMJE | 354-06, P50CA102701-08, CDR0000613100 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Gloria M. Petersen, Mayo Clinic | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Mayo Clinic | ||||
| Verification Date | January 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||