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
  Purpose

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.


Condition Intervention
Pancreatic Cancer
Other: This is a non-intervention study for all groups.
Other: study of socioeconomic and demographic variables

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Pancreatic Cancer Serum and Peripheral Blood Lymphocyte Repository

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 88
Study Start Date: May 2005
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898482

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Daniel A. Laheru, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00898482     History of Changes
Other Study ID Numbers: JHOC-J0533 CDR0000452792, P30CA006973, JHOC-J0533, JHOC-05042601
Study First Received: May 9, 2009
Last Updated: January 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 11, 2014