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Studying Biomarkers in Patients With Pancreatic Cancer

Developing Biomarkers in Pancreatic Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00900003
Enrollment
53
Registered
2009-05-12
Start date
2007-05-31
Completion date
2013-03-31
Last updated
2013-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer

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.

Interventions

GENETICprotein analysis

Using material that is already being acquired as a component of clinical care (only that which is excess after routine clinical care), we will determine if pre-treatment markers can be used to correlate with clinical outcomes of survival and recurrence. Examples of such markers include studying if the integrity of DNA repair pathway in pancreatic cancers, analyzed by Rad51 and phosphorylated DNA-PK foci formation, correlates with tumor response to radiotherapy, chemotherapy, and overall survival. The markers targeted are proteins secreted by cancer cells and/or cancer associated cells.

OTHERlaboratory biomarker analysis

A method of extracting and identifying secreted cytokines and growth factors from tissues of the quantity of typical biopsy tissues has been developed.The purpose of this study is to determine if this method of biomarker discovery can now be applied to pancreatic cancer population.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Vanderbilt-Ingram Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cellular localization of BRCA1 as a predictor of response to cytotoxic agents or radiotherapyfollowing collection of all pancreatic tissue specimens and patient outcome dataExamine the location of BRCA1 in the cells and determine if this location predicts patient response to the chemotherapy drugs given

Secondary

MeasureTime frameDescription
Correlation of pre-treatment markers with survival and recurrenceat expiration date of final patient enrolledCompare and contract of biomarkers in patient's tissue that are detected before treatment has a relationship to their survival and recurrence of their cancer
Application of a method of extracting and identifying secreted cytokines and growth factors from biopsy tissue to the pancreatic cancer populationupon collection of pancreatic tissue for each patientResearchers will determine if the methods they have developed for extracting and identifying cytokines in biopsy tissue can be applied to the pancreatic cancer tissue

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026