UMCC 003 Cancer-Related Protein Biomarkers in Blood and Tumor Tissue of Patients With Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)

Conditions
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Breast Cancer, Colorectal Cancer, Esophageal Cancer, Liver Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer

Intervention / Treatment
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* Genetic: fluorescence in situ hybridization
* Genetic: polymerase chain reaction
* Genetic: protein expression analysis
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis
* Other: mass spectrometry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: fluorescence in situ hybridization|nan|
|Genetic: polymerase chain reaction|nan|
|Genetic: protein expression analysis|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|
|Other: mass spectrometry|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of tumor antigens that induce a humoral response in cancer patients |  |  | 
| Identification of tumor-secreted proteins by special analysis in culture |  |  | 
| Tumor-secreted protein expression in tumors and preneoplastic lesions |  |  | 
| Potential markers for early detection of cancer |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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