Clinical trial NCT00900094: UMCC 003 Cancer-Related Protein Biomarkers in Blood and Tumor Tissue of Patients With Cancer
Official title: Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Colorectal Cancer
Esophageal Cancer
Liver Cancer
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Keywords: 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
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The laboratory will apply technologies for protein analysis to the detection and identification of proteins secreted by tumor cells and protein antigens that induce a humoral response in tumors. The initial targeted tumor types for the identification of potential biomarker proteins are: Colon, esophagus, ovary, lung, breast and liver

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Identification of tumor antigens that induce a humoral response in cancer patients
measure: Identification of tumor-secreted proteins by special analysis in culture
measure: Tumor-secreted protein expression in tumors and preneoplastic lesions
measure: Potential markers for early detection of cancer
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Samir M. Hanash, MD, PhD
role: STUDY_CHAIR
References: