Breast CancerIRB 2000-294NCT00900094
UMCC 003 Cancer-Related Protein Biomarkers in Blood and Tumor Tissue of Patients With Cancer
An observational study of Breast Cancer and Colorectal Cancer, run by University of Michigan Rogel Cancer Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Esophageal Cancer
- What is being tested?
- fluorescence in situ hybridization, polymerase chain reaction and protein expression analysis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2000to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The laboratory will apply technologies for protein analysis to the detection and identification of proteins secreted by tumor cells and protein antigens that induce a humoral response in tumors. The initial targeted tumor types for the identification of potential biomarker proteins are: Colon, esophagus, ovary, lung, breast and liver
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
About this study
Official title: Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)
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.
Read the 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.
- Conditions
- Breast Cancer, Colorectal Cancer, Esophageal Cancer, Liver Cancer, Lung Cancer, Ovarian Cancer
- Being tested
- fluorescence in situ hybridization, polymerase chain reaction, protein expression analysis, immunohistochemistry staining method, laboratory biomarker analysis
- 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
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Liver Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescence in situ hybridizationGenetic
polymerase chain reactionGenetic
protein expression analysisGenetic
laboratory biomarker analysisOther
mass spectrometryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJun 2000
- Primary completionDec 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Samir M. Hanash, MD, PhD, Study chair, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900094
- Sponsor's protocol ID
- CDR0000276589
- Other IDs
- U01CA084982, P30CA046592, CCUM-0003
- Acronym
- IRB 2000-294
- Status last verified
- Feb 2012
- First submitted
- 9 May 2009
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomics Biomarker Development Laboratory (Aka IRB 1999-514)
- ClinicalTrials.gov ID
- NCT00900094
- Acronym / sponsor ID
- IRB 2000-294 / CDR0000276589
- Conditions
- Breast Cancer, Colorectal Cancer, Esophageal Cancer, Liver Cancer, Lung Cancer, Ovarian 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2000
- Primary completion
- Dec 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The laboratory will apply technologies for protein analysis to the detection and identification of proteins secreted by tumor cells and protein antigens that induce a humoral response in tumors. The initial targeted tumor types for the identification of potential biomarker proteins are: Colon, esophagus, ovary, lung, breast and liver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorescence in situ hybridization | Genetic | – |
| polymerase chain reaction | Genetic | – |
| protein expression analysis | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| mass spectrometry | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir M. Hanash, MD, PhD study chair
University of Michigan Rogel Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colorectal Cancer, run by University of Michigan Rogel Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of tumor antigens that induce a humoral response in cancer patients. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2012.