UMCC 003 Cancer-Related Protein Biomarkers In Blood And Tumor Tissue Of Patients With Cancer

Study Overview

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

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.

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.

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

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

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-05-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-02-05
First Submitted that Met QC Criteria 2009-05-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-02-07
First Posted (ESTIMATED) 2009-05-12	Results First Posted N/A	Last Verified 2012-02

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

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

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

See Disease Characteristics
At least 3 weeks since prior chemotherapy or radiotherapy for metastatic or unresectable cancer
No concurrent chemotherapy
No concurrent radiotherapy

Collaborators and Investigators

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

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Samir M. Hanash, MD, PhD, University of Michigan Rogel Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record