NCT Number: NCT00900094
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
polymerase chain reaction
Geneticprotein expression analysis
Geneticimmunohistochemistry staining method
Otherlaboratory biomarker analysis
Othermass spectrometry
OtherPrimary outcomes
-
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
Sponsors and collaborators
Lead sponsor
University of Michigan Rogel Cancer Center
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)
Acronym: IRB 2000-294
Important dates
- Study start
- 2000
- Primary completion
- 2006
- Study completion
- 2007
- First posted
- May 12, 2009
- Registry last updated
- Feb 7, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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