Proteomics and Radiomics Research of Breast Cancer Markers in Tissue, Interstitial Fluid and Serum
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01042548 |
Recruitment Status :
Recruiting
First Posted : January 5, 2010
Last Update Posted : April 17, 2020
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Condition or disease |
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Breast Cancer |
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Proteomics and Radiomics Research of Breast Cancer Markers in Tissue, Interstitial Fluid and Serum |
Study Start Date : | September 2009 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | April 2021 |

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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042548
Contact: Laura Chiesa | 412-831-1320 | powersl2@upmc.edu | |
Contact: Min Sun, MD, PhD | 412-781-3744 | sunxmx@UPMC.EDU |
United States, Pennsylvania | |
UPMC St. Margaret | Recruiting |
Pittsburgh, Pennsylvania, United States, 15215 | |
Contact: Laura Chiesa 412-831-1320 powersl2@upmc.edu | |
Contact: Min Sun, MD, PhD | |
Principal Investigator: Min Sun, MD, PhD |
Responsible Party: | Min Sun, MD, PD, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT01042548 |
Other Study ID Numbers: |
09-028 |
First Posted: | January 5, 2010 Key Record Dates |
Last Update Posted: | April 17, 2020 |
Last Verified: | April 2020 |
Proteomics Breast Cancer Markers Tissue Interstitial Fluid |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |