NCT00899158

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

3.4 years

First QC Date

May 9, 2009

Last Update Submit

September 29, 2015

Conditions

CachexiaPancreatic Cancer

Keywords

recurrent pancreatic cancerstage I pancreatic cancerstage II pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancercachexia

Outcome Measures

Primary Outcomes (6)

  • Skeletal muscle loss

    Up to 6 months

  • Lean body mass

    Up to 6 months

  • Time to progression

    Up to 6 months

  • Caspase-3 levels

    Up to 6 months

  • Phosphorylated Akt levels

    Up to 6 months

  • Urinary 3-methylhistidine levels

    Up to 6 months

Interventions

immunologic techniqueOTHER
laboratory biomarker analysisOTHER
biopsyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

During surgery, a muscle biopsy is performed and approximately 1 cm of rectus abdominous muscle is obtained for analysis.

MeSH Terms

Conditions

CachexiaPancreatic Neoplasms

Interventions

Immunologic TechniquesBiopsy

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinnessDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative TechniquesCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, Operative

Study Officials

  • Joanna M. Brell, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

June 1, 2005

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

September 30, 2015

Record last verified: 2015-09

Locations

US(1)