Biological Markers in Patients With Pancreatic Cancer Experiencing Weight Loss
NCT ID: NCT00899158
Last Updated: 2015-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2005-06-30
2008-12-31
Brief Summary
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PURPOSE: This laboratory study is examining biological markers in patients with pancreatic cancer experiencing weight loss.
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Detailed Description
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* 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
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Interventions
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immunologic technique
laboratory biomarker analysis
biopsy
Eligibility Criteria
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Inclusion Criteria
* Meets 1 of the following criteria:
* Diagnosis or suspicion of pancreatic cancer
* Any stage disease allowed
* At least 5% weight loss within the past 6 months
* Scheduled to undergo exploratory surgery
* Scheduled to undergo exploratory surgery for suspected nonmalignant condition
* No weight loss OR weight loss due to specific reason (e.g., bowel obstruction, infection, or nausea/vomiting)
* No cancer diagnosis other than primary pancreatic carcinoma
PATIENT CHARACTERISTICS:
* ECOG performance status 0-3
* Life expectancy ≥ 12 weeks
* No pacemakers or implanted defibrillators
PRIOR CONCURRENT THERAPY:
* Prior or concurrent chemotherapy and radiotherapy allowed
* Prior or concurrent biological therapy and surgery allowed
* At least 4 weeks since prior corticosteroids or anabolic steroids
* Other concurrent anticancer therapy allowed
* No concurrent corticosteroids or anabolic steroids, thalidomide, eicosapentaenoic acid (EPA), or Juven for weight loss
* Concurrent steroids (i.e., antiemetics) associated with chemotherapy allowed
* No concurrent nutritional supplements with EPA
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Joanna M. Brell, MD
Role: STUDY_CHAIR
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Locations
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Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE3204
Identifier Type: OTHER
Identifier Source: secondary_id
CWRU-020541
Identifier Type: -
Identifier Source: secondary_id
CASE3204
Identifier Type: -
Identifier Source: org_study_id
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