Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)
18 Years
N/A
Both
Breast Cancer, Colorectal Cancer, Esophageal Cancer, Liver Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer
Trial Information
Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria (patient):
- Scheduled to undergo primary surgical resection or first debulking surgery
(prior to any anticancer treatment) for suspected or newly diagnosed cancer,
including any of the following types:
- Breast cancer
- Adenocarcinoma of the colon
- Adenocarcinoma or squamous cell carcinoma of the esophagus
- Non-small cell lung cancer
- Ovarian epithelial adenocarcinoma
- Metastatic or unresectable cancer, including any of the following types:
- Breast cancer
- Adenocarcinoma of the colon
- Adenocarcinoma or squamous cell carcinoma of the esophagus
- Hepatoma
- Non-small cell lung cancer
- Small cell lung cancer
- Ovarian epithelial adenocarcinoma
- Adenocarcinoma of the pancreas
- Meets the following criteria (healthy participant):
- No chronic disease
- Healthy participants with a history of cancer must be cancer-free for 5
years (skin cancer or carcinoma in situ of the cervix within the past 5
years allowed)
- Willing to provide 60 mL of blood
- Not a blood relative of an eligible and consenting cancer patient
PATIENT CHARACTERISTICS:
- 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Identification of tumor antigens that induce a humoral response in cancer patients
Safety Issue:
No
Principal Investigator
Samir M. Hanash, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Michigan Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000276589
NCT ID:
NCT00900094
Start Date:
June 2000
Completion Date:
October 2007
Related Keywords:
- Breast Cancer
- Colorectal Cancer
- Esophageal Cancer
- Liver Cancer
- Lung Cancer
- Ovarian Cancer
- Pancreatic Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IV breast cancer
- adenocarcinoma of the colon
- stage I colon cancer
- stage II colon cancer
- stage III colon cancer
- stage IV colon cancer
- adenocarcinoma of the esophagus
- squamous cell carcinoma of the esophagus
- stage I esophageal cancer
- stage II esophageal cancer
- stage III esophageal cancer
- stage IV esophageal cancer
- stage I non-small cell lung cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- localized unresectable adult primary liver cancer
- advanced adult primary liver cancer
- adenocarcinoma of the pancreas
- stage II pancreatic cancer
- stage III pancreatic cancer
- extensive stage small cell lung cancer
- stage IIIC breast cancer
- stage IV pancreatic cancer
- recurrent breast cancer
- recurrent colon cancer
- recurrent esophageal cancer
- recurrent non-small cell lung cancer
- recurrent ovarian epithelial cancer
- recurrent adult primary liver cancer
- adult primary hepatocellular carcinoma
- recurrent small cell lung cancer
- Breast Neoplasms
- Colorectal Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Liver Neoplasms
- Lung Neoplasms
- Ovarian Neoplasms
- Pancreatic Neoplasms
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