CachexiaNCT00899158
Biological Markers in Patients With Pancreatic Cancer Experiencing Weight Loss
An observational study of Cachexia and Pancreatic Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia, Pancreatic Cancer
- What is being tested?
- immunologic technique, laboratory biomarker analysis and biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
DISEASE CHARACTERISTICS:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
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
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.
Read the 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
- Cachexia, Pancreatic Cancer
- Being tested
- immunologic technique, laboratory biomarker analysis, biopsy
- Keywords
- recurrent pancreatic cancer, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer, cachexia
- Medical subject headings
- Cachexia, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunologic techniqueOther
laboratory biomarker analysisOther
biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle loss
Measured: Up to 6 months
Lean body mass
Measured: Up to 6 months
Time to progression
Measured: Up to 6 months
Caspase-3 levels
Measured: Up to 6 months
Phosphorylated Akt levels
Measured: Up to 6 months
Urinary 3-methylhistidine levels
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJun 2005
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joanna M. Brell, MD, Study chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899158
- Sponsor's protocol ID
- CASE3204
- Other IDs
- P30CA043703, CASE3204, CWRU-020541
- Status last verified
- Sep 2015
- First submitted
- 9 May 2009
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00899158
- Acronym / sponsor ID
- CASE3204
- Conditions
- Cachexia, Pancreatic Cancer
- Keywords
- recurrent pancreatic cancer, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer, cachexia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunologic technique | Other | – |
| laboratory biomarker analysis | Other | – |
| biopsy | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna M. Brell, MD study chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cachexia and Pancreatic Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle loss (time frame: Up to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2015.