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

February 5, 2012 updated by: University of Michigan Rogel Cancer Center

Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Samir M. Hanash, MD, PhD, University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

February 7, 2012

Last Update Submitted That Met QC Criteria

February 5, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000276589
  • P30CA046592 (U.S. NIH Grant/Contract)
  • U01CA084982 (U.S. NIH Grant/Contract)
  • CCUM-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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