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

2 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies collecting nipple fluid to detect breast cancer in women. The fluid is tested for cancer-related proteins using a new technology, which may find cancer earlier than current methods like mammograms.

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 data supports the effectiveness of the treatment Aspiration of Breast, Biospecimen Collection for detecting breast cancer?

Research shows that collecting nipple aspirate fluid (NAF) is a promising non-invasive method to identify markers of breast cancer risk. Studies found that abnormal NAF cytology is linked to increased breast cancer risk, and the presence of epithelial cells in NAF is associated with a higher likelihood of developing breast cancer. ^{1 2 3 4 5}

Is nipple aspirate fluid collection safe for humans?

Nipple aspirate fluid collection is generally safe, as studies have shown it can be done quickly and reliably without immediate complications in most participants. ^{1 3 6 7 8}

How does the nipple aspirate fluid detection treatment for breast cancer differ from other treatments?

This treatment is unique because it uses a non-invasive method to collect nipple aspirate fluid (NAF) to detect cellular markers that indicate breast cancer risk, unlike traditional methods that may require more invasive procedures. It allows for early detection and monitoring of breast cancer risk through the analysis of cells and DNA in the fluid, potentially serving as an adjunct to existing screening methods. ^{1 2 3 5 9}

Research Team

William Carson, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Nipple aspirate fluid: a promising non-invasive method to identify cellular markers of breast cancer risk. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Cytologic features of nipple aspirate fluid using an automated non-invasive collection device: a prospective observational study. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Presence of epithelial cells in nipple aspirate fluid is associated with subsequent breast cancer: a 25-year prospective study. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Failure of high risk women to produce nipple aspirate fluid does not exclude detection of cytologic atypia in random periareolar fine needle aspiration specimens. [2004]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Multiple sampling for increasing the diagnostic sensitivity of nipple aspirate fluid for atypical cytology. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Systematic tissue collection during clinical breast biopsy is feasible, safe and enables high-content translational analyses. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The feasibility of nipple aspiration and duct lavage to evaluate the breast duct epithelium of women with increased breast cancer risk. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Nipple aspiration and ductal lavage in women with a germline BRCA1 or BRCA2 mutation. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Pilot studies on the p53 gene in nipple aspirate fluid from patients with breast cancer. [2019]