Breast Cancer Clinical Trial
Official title:
Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)
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.
OBJECTIVES:
- 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.
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Observational Model: Cohort, Time Perspective: Prospective
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