Clinical trial · Observational
Effect of Surgery, Radiation Therapy, Chemotherapy, and Hormone Therapy on Biomarkers in Women With Stage I, Stage II, Stage III Breast Cancer, or Ductal Carcinoma In Situ That Can Be Removed By Surgery
Effects of Surgery, Radiation Therapy, Chemotherapy, and Endocrine Therapy on High-Sensitivity C-Reactive Protein in Women With Operable Breast Cancer
- 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: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at the effects of surgery, radiation therapy, chemotherapy, and hormone therapy on biomarkers in women with stage I, stage II, stage III breast cancer, or ductal carcinoma in situ that can be removed by surgery.
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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| chemotherapy | Drug | Chemotherapy | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| DNA methylation analysis | Genetic | — | UNRESOLVED |
| endocrine therapy | Drug | Hormone Therapy | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| protein analysis | Genetic | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in high-sensitivity C-reactive protein and gene methylation over time
- timeFrame
- indefinite
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically and/or cytologically confirmed stage I-III invasive breast carcinoma or ductal carcinoma in situ * Newly diagnosed disease * Patient must be initiating a new course of treatment for breast carcinoma, including surgery (mastectomy or lumpectomy with or without nodal evaluation) with or without any of the following: * Radiation therapy * Chemotherapy * Endocrine therapy * No known or suspected metastatic disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * No infectious or inflammatory condition, at the discretion of the principal investigator * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: * More than 6 months since prior surgery * Fine-needle aspirate or biopsy allowed * More than 6 months since prior radiotherapy * More than 6 months since prior chemotherapy * More than 6 months since prior endocrine therapy * No neoadjuvant endocrine therapy or chemotherapy * More than 2 weeks since prior and no concurrent regular use of any of the following: * Hydroxymethyl glutaryl coenzyme A reductase inhibitor (statin) * Nonsteroidal anti-inflammatory drug (NSAID)\* * Cyclooxygenase-2 (COX-2) inhibitor * Aspirin\* * Acetaminophen and opioid use is permitted as needed NOTE: \*Use of these products ≤ 2 times per week at standard over-the-counter doses allowed
References
Publications (0)
Data not yet available