Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT00900094
Status:
COMPLETED
Last Update Posted:
2012-02-07
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UMCC 003 Cancer-Related Protein Biomarkers in Blood and Tumor Tissue of Patients With Cancer
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
Study Overview
Official Title:
Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRB 2000-294
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.
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01CA084982 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA046592 | NIH | None | https://reporter.nih.gov/quic… | View |
| CCUM-0003 | None | None | View |