Biological Markers in Patients With Pancreatic Cancer Experiencing Weight Loss
RATIONALE: Learning about biological markers in patients with pancreatic cancer and cachexia may help doctors predict patient outcome and may help the study of cancer in the future.
PURPOSE: This laboratory study is examining biological markers in patients with pancreatic cancer experiencing weight loss.
Other: immunologic technique
Other: laboratory biomarker analysis
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Role of Caspase-3, Phosphatidylinositol-3 Kinase (PI3K), and 3-methylhistidine (3-MH) in the Pathophysiology of Skeletal Muscle Loss in Weight-losing Pancreas Cancer Patients|
- Skeletal muscle loss [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Lean body mass [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Caspase-3 levels [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Phosphorylated Akt levels [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Urinary 3-methylhistidine levels [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||June 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
- Compare levels of caspase-3 and phosphorylated Akt (pAkt) in the rectus abdominous muscle of patients with pancreatic cancer who are experiencing cachexia and are undergoing surgery for diagnosis or primary therapy with patients who have not lost weight and are undergoing abdominal surgery for nonmalignant conditions.
- Compare levels of urinary 3-methylhistidine (3-MH) in these patients.
- Evaluate possible correlations of caspase-3 activity, pAkt, and urinary 3-MH with early time to progression and subsequent lean body weight loss in patients with pancreatic cancer.
- Associate excretion of urinary 3-MH with higher levels of caspase-3 activity and pAkt to analyze the utility of 3-MH as a marker of skeletal muscle proteolysis.
OUTLINE: This is a pilot study.
During surgery, a muscle biopsy is performed and approximately 1 cm of rectus abdominous muscle is obtained for analysis. Caspase-3 activity and total/phosphorylated phosphatidylinositol-3 kinase and Akt are measured in muscle biopsies by western blot analysis. 3-methylhistidine activity is measured in urine samples.
After completion of study, patients with pancreatic cancer are followed postoperatively at 3 and 6 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899158
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Study Chair:||Joanna M. Brell, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|