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

Breast Cancer Clinical Trial

— IRB 2000-294  

Official title:

Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900094
• Other study ID #: CDR0000276589
• Secondary ID: U01CA084982P30CA
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: February 5, 2012
• Start date: June 2000
• Est. completion date: October 2007

Study information

• Verified date: February 2012
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Genetic:
• fluorescence in situ hybridization

• polymerase chain reaction

• protein expression analysis

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

• mass spectrometry

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of tumor antigens that induce a humoral response in cancer patients			No
Primary	Identification of tumor-secreted proteins by special analysis in culture			No
Primary	Tumor-secreted protein expression in tumors and preneoplastic lesions			No
Primary	Potential markers for early detection of cancer			No