Skip to content

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

Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00900094
Acronym
IRB 2000-294
Enrollment
200
Registered
2009-05-12
Start date
2000-06-30
Completion date
2007-10-31
Last updated
2012-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

GENETICfluorescence in situ hybridization
GENETICpolymerase chain reaction
GENETICprotein expression analysis
OTHERimmunohistochemistry staining method
OTHERlaboratory biomarker analysis
OTHERmass spectrometry

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Michigan Rogel Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026