Trials / Completed
CompletedNCT00899158
Biological Markers in Patients With Pancreatic Cancer Experiencing Weight Loss
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 44 (actual)
- Sponsor
- Case Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
OBJECTIVES: * 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | immunologic technique | |
| OTHER | laboratory biomarker analysis | |
| PROCEDURE | biopsy |
Timeline
- Start date
- 2005-06-01
- Primary completion
- 2008-11-01
- Completion
- 2008-12-01
- First posted
- 2009-05-12
- Last updated
- 2015-09-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00899158. Inclusion in this directory is not an endorsement.