Proteomics Research of Breast Cancer Markers in Interstitial Fluid and Serum
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Purpose
The current study is a case control study involving comparisons of tissue interstitial fluid from breast cancer and adjacent non-cancerous tissue as well as that from benign breast lesion and its adjacent non-diseased tissue for a distinguishable breast cancer profile. The purpose of this research is to collect fresh breast nodule/cancer and surrounding non-cancerous tissue for proteomic studies of the interstitial fluid to identify a profile distinguishing breast cancer which will also permit future research on stored interstitial fluid, blood or tissue samples. Specific markers identified from interstitial fluid study will be investigated in blood samples to develop serum markers for breast cancer diagnosis and prognosis. Additionally, we will perform both prospective and retrospective research on breast cancer involving clinical, demographic, epidemiologic information, treatment, follow-up and outcomes on breast nodule/cancer cases collected.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Proteomics Research of Breast Cancer Markers in Interstitial Fluid and Serum |
Subjects will be asked to allow us to collect an extra 2 tablespoons of blood at the time of pre-operative blood work. For those subjects with cancer who undergo surgery, a follow-up blood sample will be collected prior to chemotherapy, radiation, or hormonal therapy, and every six months afterwards at the time of their standard clinic/office visit for two years, then once a year for year 3-5. This will allow researchers to examine the samples to determine if blood changes over time after surgery, and what type of result may indicate a risk for recurrence.
Any remaining blood samples not used for the study will remain in the laboratory for future research.
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All patients who are receiving or seeking medical care at the UPMC St. Margaret for breast cancer will be invited to participate in the research study. Patients undergoing surgery for breast nodules suspected of being cancer or high risk lesions will also be asked to participate.
Inclusion Criteria:
- All subjects ≥ 18 years of age undergoing surgery for indeterminate breast nodules and all subjects with newly diagnosed breast cancer will be eligible to participate.
Exclusion Criteria:
- Anyone < 18 years of age.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01042548
| Contact: Cathy Van Every, BSN | 412-781-3744 ext 112 | vaneverycc@upmc.edu |
| United States, Pennsylvania | |
| UPMC St. Margaret | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15215 | |
| Contact: Cathy Van Every, BSN 412-781-3744 ext 112 vaneverycc@upmc.edu | |
| Principal Investigator: Min Sun, MD, PhD | |
More Information
No publications provided
| Responsible Party: | Min Sun, MD, PD, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01042548 History of Changes |
| Other Study ID Numbers: | 09-028 |
| Study First Received: | January 4, 2010 |
| Last Updated: | April 9, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Proteomics Breast Cancer Markers Tissue Interstitial Fluid |
Additional relevant MeSH terms:
|
Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases |
ClinicalTrials.gov processed this record on February 27, 2015