Clinical trial · Observational
Studying Biomarkers in Nipple Fluid, Urine, and Blood Samples From Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer and in Women at Risk of Developing Breast Cancer
Estrogen-DNA Adducts in Breast, Urine and Serum as Biomarkers of Breast Cancer Risk
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Studying samples of nipple fluid, urine, and blood in the laboratory from patients with cancer and from patients at risk of developing cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors learn more about breast cancer and identify patients at risk of developing breast cancer. PURPOSE: This laboratory study is looking at biomarkers in nipple fluid, urine, and blood samples from women with newly diagnosed ductal carcinoma in situ or stage I or stage II breast cancer and in women at risk of developing breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| evaluation of cancer risk factors | Procedure | — | UNRESOLVED |
| high performance liquid chromatography | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mass spectrometry | Other | — | UNRESOLVED |
| medical chart review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Comparison of the levels of estrogens, catechol estrogen (CE) metabolites, CE-glutathione conjugates, and CE-DNA adducts (N3Ade and N7Gua) among healthy women, high-risk women, and women with breast cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Meets 1 of the following criteria:
* Newly diagnosed (within 30 calendar days of diagnosis) stage I or II breast cancer
* Node-negative or node-positive disease
* Newly diagnosed ductal carcinoma in situ (stage 0) of the breast
* At high risk of developing breast cancer, as indicated by at least 1 of the following criteria:
* Gail model 5-year risk score ≥ 1.66%
* Gail model lifetime-risk estimate ≥ 20%
* Known deleterious BRCA 1 or 2 gene mutation carrier
* History of lobular carcinoma in situ or atypical ductal or lobular hyperplasia
* At low or average risk of developing breast cancer (control group)
* Gail model 5-year risk score \< 1.66% or lifetime risk \< 20%
* No advanced breast cancer
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Pre- or post-menopausal
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for breast cancer or any other cancer
* More than 3 months since prior and no concurrent estrogen or other hormones
* More than 3 months since prior oral contraceptives
* No concurrent selective estrogen receptor modulators (tamoxifen citrate or raloxifene)
* No concurrent aromatase inhibitorsReferences
Publications (0)
Data not yet available