UMCC 003 Cancer-Related Protein Biomarkers in Blood and Tumor Tissue of Patients With Cancer (IRB 2000-294)

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Breast Cancer; Esophageal Cancer; Lung Cancer; Ovarian Cancer; Liver Cancer; Pancreatic Cancer; Colorectal Cancer

Treatments: Other: laboratory biomarker analysis; Genetic: protein expression analysis; Genetic: polymerase chain reaction; Genetic: fluorescence in situ hybridization; Other: mass spectrometry; Other: immunohistochemistry staining method

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00900094

P30CA046592 (U.S. NIH Grant/Contract)

U01CA084982 (U.S. NIH Grant/Contract)

CDR0000276589

CCUM-0003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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