Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT07250204
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07250204
Study Brief:
Protocol Section:
NCT07250204