Biomarkers in Predicting Response to Treatment in Patients Who Have Undergone Surgery for Pancreatic Cancer

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

PURPOSE: This laboratory study is looking at biomarkers in predicting response to treatment in patients who have undergone surgery for pancreatic cancer.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

About this study

OBJECTIVES:

To determine if a method of extracting and identifying biomarkers (i.e., secreted cytokines and growth factors) from tissues of the quantity obtained from typical biopsy can now be applied in the setting of pancreatic cancer
To correlate pre-treatment biomarkers with recurrence, overall survival, and tumor response to radiotherapy and chemotherapy in patients with pancreatic cancer.

OUTLINE: Tumor tissue specimens are obtained from the Vanderbilt Ingram Cancer Center Human Tissue Acquisition Core and analyzed for biomarkers (e.g., integrity of DNA repair pathways as analyzed by Rad51 and phosphorylated DNA-PK foci formation). The biomarkers are correlated with clinical outcomes (recurrence, overall survival, and tumor response to treatment).

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of pancreatic cancer
Excess tissue collected at the time of routine surgery for pancreatic cancer must be available for analysis

Exclusion criteria

None known

Treatment and study plan

laboratory biomarker analysis

Other

Using material that is already being acquired as a component of clinical care (only that which is excess after routine clinical care), it will be determined 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.

Primary outcomes

Determination if a method of extracting and identifying biomarkers from tissues of the quantity obtained from typical biopsy can be applied in the setting of pancreatic cancer

Time frame: 1 year following final patient data

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Developing Predictive Markers of Therapeutic Response in Pancreatic Cancer

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: May 12, 2009
Registry last updated: Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed