UMCC 003 Cancer-Related Protein Biomarkers in Blood and Tumor Tissue of Patients With Cancer (IRB 2000-294)
RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer and blood from healthy participants may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
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.
Genetic: fluorescence in situ hybridization
Genetic: polymerase chain reaction
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: mass spectrometry
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)|
- Identification of tumor antigens that induce a humoral response in cancer patients [ Designated as safety issue: No ]
- Identification of tumor-secreted proteins by special analysis in culture [ Designated as safety issue: No ]
- Tumor-secreted protein expression in tumors and preneoplastic lesions [ Designated as safety issue: No ]
- Potential markers for early detection of cancer [ Designated as safety issue: No ]
|Study Start Date:||June 2000|
|Study Completion Date:||October 2007|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900094
|Study Chair:||Samir M. Hanash, MD, PhD||University of Michigan Cancer Center|