Clinical trial NCT00296114: Pancreatic Cancer Serum and DNA Repository
Official title: Pancreatic Cancer Serum and DNA Repository
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cancer
Keywords: Cancer
Pancreas
Lead sponsor: Pancreatic Cancer Research Team
Sponsor class: OTHER
First posted: 2006-02-24
Enrollment: 690
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples are collected on: Pancreatic Cancer, Liver Disease, Pancreatitis, Healthy and Healthy at Risk Subjects.

Brief summary: To prospectively collect serum and DNA samples from subjects with pancreatic cancer, pancreatitis, liver disease, and from healthy and at-risk volunteers in order to identify novel biomarkers for early diagnosis, differential diagnosis, stage, natural history of the disease, response to treatment, and to identify novel targets for therapeutic interventions. In particular:

Detailed description: * To establish a central pancreatic cancer specimen repository to serve as a resource for current and future scientific studies.
* To utilize the PCRT clinical data base to perform clinicopathologic correlation with the results of those studies.
* To test new hypotheses as they emerge.

Eligibility criteria: Inclusion Criteria:

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

4.1 At the time of subject registration, CRAB will verify the institution's IRB date to ensure that the subject can be enrolled.

4.2 Potential study participants must meet the eligibility criteria found in Section 12.0 (Eligibility Checklist). Candidates will fall into one of four groups:

1. Pancreatic cancer patients;
2. Pancreatic and Liver Disease patients;
3. Healthy, At-Risk Volunteers (smoker, (defined as individuals who have smoked \>= 100 cigarettes in their lifetime, and who currently smoke every day or some days \[MMWR November 12, 2004, 53(44);1035-1037\]), diabetic, and/or family history); and
4. Healthy Volunteers (no history of cancer). The Eligibility Checklist must be photocopied, completed and stored on site. Eligibility is confirmed during registration, by answering yes to the question, Have all eligibility criteria been met? on the Registration Form.

Eligibility Checklist:

1. Pancreatic Cancer Patient Criteria All subjects, regardless of gender and ethnicity are eligible for this study Pathological diagnosis of pancreatic malignant neoplasm Expected availability of clinical follow up data Eighteen years old or older All subjects must be informed of the investigational nature of this protocol Written, informed consent obtained in accordance with institutional and federal guidelines
2. Pancreatitis and Liver Disease Subject Criteria All subjects, regardless of gender and ethnicity are eligible for this study Pathological diagnosis of pancreatitis or liver disease Eighteen years old or older All subjects must be informed of the investigational nature of this protocol Written, informed consent obtained in accordance with institutional and federal guidelines
3. Healthy, At-Risk Volunteers All subjects, regardless of gender and ethnicity are eligible for this study Is a smoker, is diabetic AND/OR has a family history of pancreatic cancer Eighteen years old or older with no history of cancer All subjects must be informed of the investigational nature of this protocol Written, informed consent obtained in accordance with institutional and federal guidelines
4. Healthy Volunteers (no at-risk factors) All subjects, regardless of gender and ethnicity are eligible for this study Eighteen years old or older with no history of cancer All subjects must be informed of the investigational nature of this protocol Written, informed consent obtained in accordance with institutional and federal guidelines

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Tucson
country: United States
facility: University of Arizona/Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Chicago
country: United States
facility: RUSH University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins
state: Maryland
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital/Virginia Piper Cancer Institute
state: Minnesota
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology
state: Texas
city: Madrid
country: Spain
facility: University Hospital (12 De Octubre)
Study officials:
affiliation: Hospital Universitario Sanchinarro, Madrid, Spain
name: Manuel Hidalgo, MD, PhD
role: STUDY_CHAIR
References: