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

Pancreatic Cancer Clinical Trial

Official title:

Pancreatic Cancer Serum and Peripheral Blood Lymphocyte Repository

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898482
• Other study ID #: JHOC-J0533 CDR0000452792
• Secondary ID: P30CA006973JHOC-
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: November 17, 2015
• Start date: May 2005
• Est. completion date: June 2011

Study information

• Verified date: November 2015
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Cancer Institute (NCI)

Outcome

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