Nipple Aspirate Fluid Detection for Breast Cancer

Overseen By William Carson, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Pregnancy, Other cancers, Male, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if nipple aspirate fluid can detect breast cancer earlier than traditional methods like mammograms. Researchers will collect fluid from participants' nipples to analyze for cancer signs. They seek women who either have breast cancer without recent treatment or are healthy with no cancer history. Healthy participants should also have had a recent breast exam or mammogram showing no cancer signs. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to earlier breast cancer detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for detecting breast cancer?

Research has shown that collecting nipple aspirate fluid (NAF) is generally safe and well-tolerated. In studies with healthy volunteers, the fluid was successfully collected 94% of the time and 84% for each breast, indicating that most people can undergo the procedure without major issues.

No reports of serious side effects have emerged from NAF collection. The procedure uses gentle suction to gather fluid from the nipple, making it non-invasive and free from surgical intervention. Overall, it seems to be a safe method for gathering information that could aid in early breast cancer detection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of nipple aspirate fluid for breast cancer detection because it offers a non-invasive and potentially less uncomfortable alternative to traditional methods like mammograms and biopsies. Unlike these standard procedures, which can be more invasive and require specialized equipment, the nipple aspiration technique simply involves collecting fluid from the nipple, which may contain cancer markers. This approach could make routine screening more accessible and less intimidating, encouraging more regular check-ups and potentially catching cancer earlier.

What evidence suggests that nipple aspirate fluid is effective for detecting breast cancer?

This trial will collect nipple aspirate fluid to explore its potential as a tool for early breast cancer detection. Studies have shown that fluid from the nipple can be useful for this purpose. Research indicates that certain elements in this fluid can serve as biomarkers, suggesting the presence of cancer. For example, some studies found that unusual changes in nipple fluid linked to a higher risk of breast cancer. Specifically, women with abnormal cell growth or changes in their nipple fluid were 2.5 to 4.9 times more likely to develop breast cancer. Additionally, certain markers in the fluid, like miRNAs, can help distinguish between women with cancer and those without, making it a potentially useful screening method. ^{2 6 7 8 9}

Who Is on the Research Team?

William Carson, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for women over a year removed from pregnancy or lactation, with current breast cancer diagnosis or healthy subjects without any cancer. Healthy participants must have had a recent non-suspicious breast exam/mammogram. Exclusions include men, those pregnant/lactating within the last year, and anyone with cancers other than breast.

Inclusion Criteria

You must be more than 1 year past your last pregnancy or breastfeeding.

HEALTHY SUBJECTS: Must be > 1 year from pregnancy, lactation.

HEALTHY SUBJECTS: Must be willing to have a clinical breast exam and/or mammogram performed or reviewed by an Ohio State University (OSU) radiologist at the James Cancer Hospital within the past 90 days prior to their NAF procedure. The clinical breast exam result and/or mammograms must be read as not suspicious for breast cancer.

Exclusion Criteria

Subjects who cannot give an informed consent.

Male gender of any age.

Subjects who are currently pregnant, lactating, or within a year of pregnancy/lactation. Pregnancy testing will not be required of any patients over 60 years of age, or any patient who has undergone bilateral oophorectomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Participants undergo collection of nipple aspirate fluid from both breasts

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after sample collection

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Aspiration of Breast
• Biospecimen Collection

Trial Overview The study is examining nipple aspirate fluid to see if it's more effective at early detection of breast cancer compared to traditional screening methods like mammograms and clinical exams.

How Is the Trial Designed?

Group I: Diagnostic (nipple aspiration fluid) Experimental Treatment 2 Interventions

Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11212179/

Early detection of breast cancer through the diagnosis of ... One such fluid is the Nipple Aspirate Fluid (NAF) which can help in the screening for breast cancer. Several other fluids secreted from breasts ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2049080122003855

Nipple aspirate fluid and its use for the early detection of ... This review evaluates the use of new technologies to evaluate the components of nipple fluid and their potential to serve as biomarkers in screening.

3. academic.oup.com academic.oup.com/jnci/article/93/23/1791/2519649?login=true

Breast Cancer Risk in Women With Abnormal Cytology in ... We previously showed that women with epithelial hyperplasia and atypia diagnosed in nipple aspirates of breast fluids (3,4,10) were 2.5 and 4.9 times more ...

4. aacrjournals.org aacrjournals.org/clincancerres/article/10/1/28/165819/Detection-of-Breast-Cancer-in-Nipple-Aspirate

Detection of Breast Cancer in Nipple Aspirate Fluid by CpG ... Abstract. Purpose: New approaches to the early detection of breast cancer are urgently needed as there is more benefit to be realized from screening.

5. esmoopen.com esmoopen.com/article/S2059-7029(24)00962-1/pdf

Results These results indicate that the nipple fluid derived miRNAs are able to differentiate between women with BC and healthy controls. A paired analysis within. BC ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8750428/

Nipple Aspirate Fluid at a Glance - PMC Nipple aspirate fluid (NAF) is a promising source of markers for detection of breast cancer. NAF can be acquired via the nipple by aspiration using a suction ...

7. clinicalproteomicsjournal.biomedcentral.com clinicalproteomicsjournal.biomedcentral.com/articles/10.1186/s12014-024-09495-4

Early detection of breast cancer through the diagnosis of ... One such fluid is the Nipple Aspirate Fluid (NAF) which can help in the screening for breast cancer.

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0127895

Repeated Nipple Fluid Aspiration: Compliance and Feasibility ... Our first experience with NFA was obtained in healthy volunteers, where aspiration was successful in 94% of patients and in 84% per breast.

9. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/oxford/cytological-exam-breast-fluids-cancer-screening-ohp.pdf

Cytological Examination of Breast Fluids for Cancer ... Nipple Aspirate Fluid (NAF)​​ Results of studies evaluating the use of NAF for use in breast cancer screening, breast cancer diagnosis, or ...