UMCC 003 Cancer-Related Protein Biomarkers in Blood and Tumor Tissue of Patients With Cancer
NCT ID: NCT00900094
Last Updated: 2012-02-07
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
200 participants
OBSERVATIONAL
2000-06-30
2007-10-31
Brief Summary
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PURPOSE: This laboratory study is looking at cancer-related protein biomarkers in the blood and tumor tissue of patients with cancer and in the blood of healthy participants.
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Detailed Description
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* Identify tumor antigens that induce a humoral response in patients with cancer.
* Identify tumor-secreted proteins by special analysis in culture, and evaluate their expression patterns in tumors and preneoplastic lesions to further assess their potential specificity.
* Determine serum positivity and specificity of potential markers for early detection of cancer.
OUTLINE: This is a multicenter study.
Patients and healthy participants undergo blood collection. Patients with suspected or newly diagnosed disease undergo a second blood collection between 4-10 weeks after surgery (but before any additional cytotoxic therapy or radiotherapy) provided they had a surgical resection with negative margin. All patients are asked questions about family history of cancer, the development of their cancer, other medical history, past and present smoking history, and menstrual period for females.
DNA is extracted from the blood and from patient tumor tissue samples obtained during surgery. Immunohistochemistry (including polymerase chain reaction) and in situ hybridization are used to analyze protein expression patterns, after proteins are identified by mass spectrometry and amino acid sequencing.
PROJECTED ACCRUAL: A total of 3,150 patients and 1,200 healthy participants will be accrued for this study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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fluorescence in situ hybridization
polymerase chain reaction
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
mass spectrometry
Eligibility Criteria
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Inclusion Criteria
* Able to tolerate the removal of 30-60 mL of blood
* No feelings of light-headedness, dizziness, or fainting within the past 2 weeks
* Pulse less than 100 on day of blood draw for study enrollment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy or radiotherapy for metastatic or unresectable cancer
* No concurrent chemotherapy
* No concurrent radiotherapy
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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University of Michigan Comprehensive Cancer Center
Principal Investigators
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Samir M. Hanash, MD, PhD
Role: STUDY_CHAIR
University of Michigan Rogel Cancer Center
Other Identifiers
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