Clinical trial NCT00900003: Studying Biomarkers in Patients With Pancreatic Cancer
Official title: Developing Biomarkers in Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with cancer of the pancreas

Brief summary: RATIONALE: Studying samples of tissue in the laboratory from patients with cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in patients with pancreatic cancer.

Detailed description: OBJECTIVES:

* To determine whether the cellular localization of BRCA1 can predict how patients with pancreatic cancer will respond to cytotoxic agents (e.g., fluorouracil or gemcitabine hydrochloride) or radiotherapy.
* To identify pre-treatment markers that can be used to correlate with clinical outcomes of survival and recurrence.
* To determine if a method of extracting and identifying secreted cytokines and growth factors from biopsy tissue can now be applied to the pancreatic cancer population.

OUTLINE: Tissue samples from biopsies performed during pancreatectomy are collected from the Vanderbilt Ingram Cancer Center Human Tissue Acquisition Core for laboratory biomarker studies. Proteins secreted by cancer cells and/or cancer-associated cells are studied by extracting and identifying secreted cytokines and growth factors from biopsy tissue. The integrity of the DNA repair pathway in pancreatic cancer is analyzed by Rad51 and phosphorylated DNA-PK foci formation. Markers are correlated with clinical outcome.

Patients are followed for recurrence, relapse, and death from disease.

Eligibility criteria: Inclusion criteria

* Any subject with excess tissue collected at time of routine surgery for pancreatic cancer is eligible.
* All subjects participating in this protocol will be followed for recurrence, relapse and death from disease

Primary outcomes:
measure: Cellular localization of BRCA1 as a predictor of response to cytotoxic agents or radiotherapy
timeFrame: following collection of all pancreatic tissue specimens and patient outcome data
Secondary outcomes:
measure: Correlation of pre-treatment markers with survival and recurrence
timeFrame: at expiration date of final patient enrolled
measure: Application of a method of extracting and identifying secreted cytokines and growth factors from biopsy tissue to the pancreatic cancer population
timeFrame: upon collection of pancreatic tissue for each patient
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: A. Bapsi Chakravarthy, MD
role: STUDY_CHAIR
References: