Pancreatic Cancer Serum and DNA Repository - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 22, 2006

Last Updated Date

March 28, 2006

Start Date ^†

February 2004

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00296114 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Pancreatic Cancer Serum and DNA Repository

Official Title ^†

Pancreatic Cancer Serum and DNA Repository

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:

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.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Screening, Longitudinal, Defined Population, Prospective Study

Condition ^†

Pancreas Cancer

Intervention ^†

Procedure: To collect serum and DNA samples from subjects

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

3500

Completion Date

Primary Completion Date

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:

Pancreatic cancer patients;
Pancreatic and Liver Disease patients;
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
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:

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
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
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
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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Cindy Lentz	602 358 8312	clentz@tgen.org
Contact: Amy Stoll, MS	602 358 8319	astoll@tgen.org

Location Countries ^†

United States, Spain

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00296114

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Pancreatic Cancer Research Team

Collaborators ^††

Investigators ^†

Study Chair:

Manuel Hidalgo, MD, PhD

Johns Hopkins University

Information Provided By

Pancreatic Cancer Research Team

Verification Date

March 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.