|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Computer Tools for Improving Early Diagnosis and Treatment in Healthy Volunteers or Patients With Pancreatic Cancer or Who Are At Risk For Pancreatic Cancer or Who Have a Noncancer Pancreatic Disorder | ||||
| Official Title † | Development of the Pancreatic Cancer Collaborative Registry and Risk Assessment Models; 2) Biomedical Computing Tools for Pancreatic Cancer Research; 3) Pancreatic Cancer Pre-Validation Reference Set for Serum/Plasma Biomarkers; 4) Semantically Integrative Pancreatic Cancer Registry (SRC) | ||||
| Brief Summary | RATIONALE: Gathering information about patients with cancer may help doctors learn more about the disease and plan early diagnosis and treatment. PURPOSE: This clinical trial is studying computer tools for improving early diagnosis and treatment in patients with pancreatic cancer, are at risk for pancreatic cancer, or have a non-cancerous pancreatic disorder. |
||||
| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients undergo blood and pancreatic tissue collection. Normal, tumor, and/or metastatic pancreatic cancer tissue, and/or paraffin-embedded tissue from prior surgery or biopsy are obtained. Patients provide or complete personal information about themselves, their medical history, their diet and lifestyle habits, any past or current environmental exposures, and re-create their family tree for any cancers that have occurred in any of their family members. Clinical data is collected annually. Control participants provide blood samples and complete questionnaires at baseline. Clinical data is collected annually. PROJECTED ACCRUAL: A total of 60 patients per group (i.e., cancer cases, healthy controls, acute biliary obstruction cases, and chronic pancreatitis cases) for a total of 240 patients will be accrued for this study. |
||||
| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | |||||
| Primary Outcome Measure † | Development of integrated Biomedical Computing Tools [ Designated as safety issue: No ] Development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure as a repository for socio-demographic, environmental, clinical, and family history data [ Designated as safety issue: No ] Participation in the international pancreatic registry known as the PCCR by sharing information [ Designated as safety issue: No ] Collection and banking of excess biological materials (i.e., pancreatic tissue, tumor tissue ,and/or metastatic pancreatic cancer tissue, and/or paraffin-embedded tissue), blood, and serum [ Designated as safety issue: No ] Establishment of an infrastructure with core data elements and standardized operating procedures for specimen collection, processing, and storage [ Designated as safety issue: No ] |
||||
| Secondary Outcome Measure † | |||||
| Condition † | Pancreatic Cancer | ||||
| Intervention † | Procedure: biopsy Procedure: medical chart review Procedure: questionnaire administration Procedure: study of socioeconomic and demographic variables |
||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 240 | ||||
| Start Date † | February 2003 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00661882 | ||||
| Organization ID | CDR0000582361 | ||||
| Secondary IDs †† | UNMC-40502 | ||||
| Study Sponsor † | University of Nebraska | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | April 18, 2008 | ||||
| Last Updated Date | October 8, 2008 | ||||