Biomarkers in Predicting Response to Treatment in Patients Who Have Undergone Surgery for Pancreatic Cancer
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| ClinicalTrials.gov Identifier: NCT00897832 |
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Recruitment Status :
Completed
First Posted : May 12, 2009
Last Update Posted : March 5, 2013
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Pancreatic Cancer | Other: laboratory biomarker analysis |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 50 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Developing Predictive Markers of Therapeutic Response in Pancreatic Cancer |
| Study Start Date : | January 2007 |
| Actual Primary Completion Date : | December 2007 |
| Actual Study Completion Date : | December 2007 |
| Group/Cohort | Intervention/treatment |
|---|---|
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pancreatic cancer
Patients with pancreatic cancer
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Other: laboratory biomarker analysis
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. |
- 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 ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897832
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center at Franklin | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| Study Chair: | A. Bapsi Chakravarthy, MD | Vanderbilt-Ingram Cancer Center |
| Responsible Party: | A Bapsi Chakravarthy, MD, Associate Professor; Radiation Oncologist, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00897832 History of Changes |
| Other Study ID Numbers: |
VICC GI 0666 P30CA068485 ( U.S. NIH Grant/Contract ) VU-VICC-GI-0666 VU-VICC-061225 |
| First Posted: | May 12, 2009 Key Record Dates |
| Last Update Posted: | March 5, 2013 |
| Last Verified: | March 2013 |
Keywords provided by A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center:
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pancreatic cancer |
Additional relevant MeSH terms:
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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |