Biological Markers in Patients With Pancreatic Cancer Experiencing Weight Loss
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|ClinicalTrials.gov Identifier: NCT00899158|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : September 30, 2015
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.
|Condition or disease||Intervention/treatment|
|Cachexia Pancreatic Cancer||Other: immunologic technique Other: laboratory biomarker analysis Procedure: biopsy|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||44 participants|
|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|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||December 2008|
- Skeletal muscle loss [ Time Frame: Up to 6 months ]
- Lean body mass [ Time Frame: Up to 6 months ]
- Time to progression [ Time Frame: Up to 6 months ]
- Caspase-3 levels [ Time Frame: Up to 6 months ]
- Phosphorylated Akt levels [ Time Frame: Up to 6 months ]
- Urinary 3-methylhistidine levels [ Time Frame: Up to 6 months ]
Biospecimen Retention: Samples With DNA
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): 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|