Breast CancerNCT01042548
Proteomics and Radiomics Research of Breast Cancer Markers in Tissue, Interstitial Fluid and Serum
An observational study of Breast Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2010to Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: 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, breast tissue reduction, or prophylactic mastectomy will also be asked to participate.
Who may be able to join
- All subjects ≥ 18 years of age undergoing surgery for indeterminate breast nodules, breast tissue reduction, prophylactic mastectomy, and all subjects with newly diagnosed invasive breast cancer will be eligible to participate. If invasive breast cancer or suspicion of invasive breast cancer, target lesion must measure ≥ 1.0 cm on breast imaging before core biopsy.
Who cannot join
- Anyone < 18 years of age.
- Multiple synchronous primary malignancies from different organ systems.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC St. Margaret
Pittsburgh, Pennsylvania, 15215
Laura Chiesa, 412-831-1320, powersl2@upmc.edu
Min Sun, MD, PhD
About this study
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.
- Conditions
- Breast Cancer
- Keywords
- Proteomics, Breast Cancer Markers, Tissue Interstitial Fluid
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study start3 Feb 2010
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
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 PittsburghThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- David Scaife Foundation
- Responsible party
- Principal investigator, Min Sun, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042548
- Sponsor's protocol ID
- 09-028
- Status last verified
- May 2026
- First submitted
- 4 Jan 2010
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomics and Radiomics Research of Breast Cancer Markers in Tissue, Interstitial Fluid and Serum
- ClinicalTrials.gov ID
- NCT01042548
- Acronym / sponsor ID
- 09-028
- Conditions
- Breast Cancer
- Keywords
- Proteomics, Breast Cancer Markers, Tissue Interstitial Fluid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- David Scaife Foundation
- Study start
- 3 Feb 2010 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 5 Jan 2010 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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, breast tissue reduction, or prophylactic mastectomy will also be asked to participate.
Key inclusion criteria (1 listed)
- All subjects ≥ 18 years of age undergoing surgery for indeterminate breast nodules, breast tissue reduction, prophylactic mastectomy, and all subjects with newly diagnosed invasive breast cancer will be eligible to participate. If invasive breast cancer or suspicion of invasive breast cancer, target lesion must measure ≥ 1.0 cm on breast imaging before core biopsy.
Key exclusion criteria (2 listed)
- Anyone < 18 years of age.
- Multiple synchronous primary malignancies from different organ systems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Chiesa (412-831-1320, powersl2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 May 2026.