Collecting And Storing Samples Of Blood From Patients With Pancreatic Cancer And Healthy Participants

Study Overview

Collecting and Storing Samples of Blood From Patients With Pancreatic Cancer and Healthy Participants

RATIONALE: Collecting and storing samples of blood from patients with cancer and healthy participants to test in the laboratory may help the study of cancer in the future. PURPOSE: This study is collecting and storing samples of blood from patients with pancreatic cancer and healthy participants.

OBJECTIVES: * Establish a central pancreatic cancer specimen (including serum and peripheral blood lymphocytes) repository to serve as a resource for current or future scientific studies. * Utilize the clinical database to perform clinicopathologic correlation with the results of those studies. * Test new hypotheses as they emerge. OUTLINE: This is a prospective study. Blood is collected from patients with pancreatic cancer at baseline and then every 3-6 months for up to 2 years. All other participants have blood collected at baseline and complete questionnaires at baseline and then every 3-6 months for up to 2 years. Serum and peripheral blood lymphocytes obtained from the blood samples are frozen and stored. PROJECTED ACCRUAL: A total of 200 patients and 200 other participants will be accrued for this study.

Pancreatic Cancer

OTHER: This is a non-intervention study for all groups.
OTHER: study of socioeconomic and demographic variables

JHOC-J0533 CDR0000452792
P30CA006973 (U.S. NIH Grant/Contract)
JHOC-J0533
JHOC-05042601

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-05-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-11-17
First Submitted that Met QC Criteria 2009-05-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-11-20
First Posted (ESTIMATED) 2009-05-12	Results First Posted N/A	Last Verified 2015-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Healthy individuals	OTHER: This is a non-intervention study for all groups. This is a non-intervention study. OTHER: study of socioeconomic and demographic variables Non-intervention study.
: At risk individuals	OTHER: This is a non-intervention study for all groups. This is a non-intervention study. OTHER: study of socioeconomic and demographic variables Non-intervention study.
: Cancer patients	OTHER: This is a non-intervention study for all groups. This is a non-intervention study. OTHER: study of socioeconomic and demographic variables Non-intervention study.

Participant Group/Arm

Intervention/Treatment

: Healthy individuals

OTHER: This is a non-intervention study for all groups.

This is a non-intervention study.

OTHER: study of socioeconomic and demographic variables

Non-intervention study.

: At risk individuals

OTHER: This is a non-intervention study for all groups.

This is a non-intervention study.

OTHER: study of socioeconomic and demographic variables

Non-intervention study.

: Cancer patients

OTHER: This is a non-intervention study for all groups.

This is a non-intervention study.

OTHER: study of socioeconomic and demographic variables

Non-intervention study.

Primary Outcome Measures	Measure Description	Time Frame
Establishment of a central pancreatic cancer specimen repository		No time frame
Utilization of the clinical database to perform clinicopathologic correlation with the results of current or future scientific studies		No time frame
Test new hypotheses as they emerge		No time frame

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

Meets 1 of the following criteria:

Histologically confirmed pancreatic malignant neoplasm
Serologically or image-confirmed diagnosis of pancreatitis or nonmalignant pancreatic disease
Healthy, at-risk participant meeting the following criteria:

Smoker, diabetic, and/or has a family history of pancreatic cancer
Healthy participant (no history of cancer)

Not specified

Not specified

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Daniel A. Laheru, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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