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

NCT ID: NCT00898482

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Groups

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Healthy individuals

This is a non-intervention study for all groups.

Intervention Type OTHER

This is a non-intervention study.

study of socioeconomic and demographic variables

Intervention Type OTHER

Non-intervention study.

At risk individuals

This is a non-intervention study for all groups.

Intervention Type OTHER

This is a non-intervention study.

study of socioeconomic and demographic variables

Intervention Type OTHER

Non-intervention study.

Cancer patients

This is a non-intervention study for all groups.

Intervention Type OTHER

This is a non-intervention study.

study of socioeconomic and demographic variables

Intervention Type OTHER

Non-intervention study.

Interventions

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This is a non-intervention study for all groups.

This is a non-intervention study.

Intervention Type OTHER

study of socioeconomic and demographic variables

Non-intervention study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* 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)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel A. Laheru, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other Identifiers

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P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JHOC-J0533

Identifier Type: -

Identifier Source: secondary_id

JHOC-05042601

Identifier Type: -

Identifier Source: secondary_id

JHOC-J0533 CDR0000452792

Identifier Type: -

Identifier Source: org_study_id