Minimal-invasive DNA test on nipple fluid to tell benign from malignant nipple discharge

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center observational study collects nipple fluid and a blood sample from adults with spontaneous, unilateral bloody or serosanguinous nipple discharge who are slated for standard diagnostic surgery. Researchers perform low-pass whole-genome analysis and methylome testing on the nipple fluid DNA to see if the results can differentiate benign disease from breast cancer. The goal is to develop a minimally invasive test that could reduce unnecessary surgeries while still identifying cancers. Enrollment is planned for about 30 participants at Hubei Cancer Hospital. The study leverages samples obtained before surgery and uses pathology results and clinical data to evaluate diagnostic performance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years.
2. Spontaneous, unilateral, single-duct pathologic nipple discharge, predominantly bloody or serosanguinous, raising clinical suspicion of intraductal disease.
3. Planned diagnostic breast surgery/biopsy after specialist assessment (e.g., duct excision/microdochectomy, lumpectomy); patients who had ductoscopy but are still scheduled for surgery remain eligible.
4. Study sampling (nipple discharge and one peripheral blood tube) feasible before surgery/invasive diagnostics without delaying standard care.
5. Able and willing to provide written informed consent and allow access to surgical pathology and relevant clinical data.

Exclusion Criteria:

1. Physiologic or non-pathologic discharge (typically bilateral, multiduct, expressible only with manipulation; milky/clear/green) or galactorrhea due to endocrine/drug causes.
2. Active breast infection/inflammatory disease (e.g., abscess) as the source of discharge.
3. Prior diagnosis and treatment of breast cancer (surgery/radiation/systemic therapy).
4. Recent invasive ductal manipulation likely to confound analysis (e.g., ductoscopy, duct cannulation/irrigation), per investigator judgment.
5. Pregnant or lactating patients.
6. Significant hematologic disease/coagulopathy precluding safe sampling.
7. Inability to complete preoperative study sampling, refusal/withdrawal of consent, or poor compliance.
8. Any condition judged by investigators to compromise sample quality, data interpretation, or participant safety.

Where it's running

• Wu Xinhong
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Xinhong Wu Principal Investigator
• Email: wuxinhong_9@sina.com
• Phone: +8618602726300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.