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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00898482
First received: May 9, 2009
Last updated: January 27, 2012
Last verified: January 2012

May 9, 2009
January 27, 2012
May 2005
June 2011   (final data collection date for primary outcome measure)
  • Establishment of a central pancreatic cancer specimen repository [ Time Frame: No time frame ] [ Designated as safety issue: No ]
  • Utilization of the clinical database to perform clinicopathologic correlation with the results of current or future scientific studies [ Time Frame: No time frame ] [ Designated as safety issue: No ]
  • Test new hypotheses as they emerge [ Time Frame: No time frame ] [ Designated as safety issue: No ]
  • Establishment of a central pancreatic cancer specimen repository [ Designated as safety issue: No ]
  • Utilization of the clinical database to perform clinicopathologic correlation with the results of current or future scientific studies [ Designated as safety issue: No ]
  • Test new hypotheses as they emerge [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00898482 on ClinicalTrials.gov Archive Site
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Collecting and Storing Samples of Blood From Patients With Pancreatic Cancer and Healthy Participants
Pancreatic Cancer Serum and Peripheral Blood Lymphocyte Repository

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.

Observational
Observational Model: Case-Only
Not Provided
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Probability Sample

The three cohorts are: 1) Healthy individuals, 2) At risk individuals and 3) Cancer patients.

Pancreatic Cancer
  • 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.
  • Healthy individuals
    Interventions:
    • Other: This is a non-intervention study for all groups.
    • Other: study of socioeconomic and demographic variables
  • At risk individuals
    Interventions:
    • Other: This is a non-intervention study for all groups.
    • Other: study of socioeconomic and demographic variables
  • Cancer patients
    Interventions:
    • Other: This is a non-intervention study for all groups.
    • Other: study of socioeconomic and demographic variables
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00898482
JHOC-J0533 CDR0000452792, P30CA006973, JHOC-J0533, JHOC-05042601
No
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Daniel A. Laheru, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP