Pancreatic Cancer Serum and DNA Repository

Pancreas Cancer Clinical Trial

Official title:

Pancreatic Cancer Serum and DNA Repository

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296114
• Other study ID #: PCRT 03 001
• Status: Completed
• Phase: N/A
• First received: February 22, 2006
• Last updated: April 29, 2013
• Start date: February 2004
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Pancreatic Cancer Research Team
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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:

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.

Other known NCT identifiers

• NCT00250107

Recruitment information / eligibility

• Status: Completed
• Enrollment: 690
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Serum and DNA Samples
To collect serum and DNA samples from subjects

Locations

Country	Name	City	State
Spain	University Hospital (12 De Octubre)	Madrid
United States	University of New Mexico	Albuquerque	New Mexico
United States	Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins	Baltimore	Maryland
United States	RUSH University Medical Center	Chicago	Illinois
United States	UCLA Medical Center	Los Angeles	California
United States	Abbott Northwestern Hospital/Virginia Piper Cancer Institute	Minneapolis	Minnesota
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	South Texas Oncology and Hematology	San Antonio	Texas
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	University of Arizona/Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Pancreatic Cancer Research Team

Countries where clinical trial is conducted

United States,  Spain, 

External Links

•   Pancreatic Cancer Research Team - Public/Members