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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00900094
First received: May 9, 2009
Last updated: February 5, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Colorectal Cancer
Esophageal Cancer
Liver Cancer
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Genetic: fluorescence in situ hybridization
Genetic: polymerase chain reaction
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: mass spectrometry

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Identification of tumor antigens that induce a humoral response in cancer patients [ Designated as safety issue: No ]
  • Identification of tumor-secreted proteins by special analysis in culture [ Designated as safety issue: No ]
  • Tumor-secreted protein expression in tumors and preneoplastic lesions [ Designated as safety issue: No ]
  • Potential markers for early detection of cancer [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: June 2000
Study Completion Date: October 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900094

Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Study Chair: Samir M. Hanash, MD, PhD University of Michigan Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Dean Brenner, University of Michigan Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00900094     History of Changes
Other Study ID Numbers: CDR0000276589, U01CA084982, P30CA046592, CCUM-0003
Study First Received: May 9, 2009
Last Updated: February 5, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Michigan Cancer Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Head and Neck Neoplasms
Esophageal Diseases
Liver Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 22, 2014