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Breast Cancer (locally Advanced Or Metastatic) / Healthy Volunteers (HV) / Unhealthy Volunteers · Observational Study
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry record describing a planned observational study to develop and validate an epigenetic blood-based assay for breast cancer diagnosis. No results have been reported; the study has not yet begun recruitment. The record documents the intended scope and follow-up duration but provides no evidence of efficacy, accuracy, or clinical utility.
Observational. Breast Cancer (Locally Advanced or Metastatic), Healthy Volunteers (HV), Unhealthy Volunteers, Breast Cancer Screening; age from 18 Years; accepts healthy volunteers. Intervention: Study Population 1; Study Population 2; Study Population 3. n = 450. 1 site: United States.
This is a clinical trial registry record describing a planned observational study to develop and validate an epigenetic blood-based assay for breast cancer diagnosis. No results have been reported; the study has not yet begun recruitment. The record documents the intended scope and follow-up duration but provides no evidence of efficacy, accuracy, or clinical utility.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This record does not provide results or evidence to guide clinical practice. Readers should monitor for publication of findings once the study completes; no clinical recommendations can be derived from this planning document.
This is a registry record for a planned observational study of an epigenetic assay signature development and validation; no results are reported, and recruitment has not yet begun.
As stated by the source record.
Quoted from the source exactly as published.
This record does not provide results or evidence to guide clinical practice. Readers should monitor for publication of findings once the study completes; no clinical recommendations can be derived from this planning document.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07374796). This is a study registration, not published results. Lead sponsor: University of Maryland, Baltimore. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 450 participants (ESTIMATED). Conditions: Breast Cancer (Locally Advanced or Metastatic), Healthy Volunteers (HV), Unhealthy Volunteers, Breast Cancer Screening. Interventions: OTHER: Epigenetic Assay. Primary outcome measures: Identification of tumor-associated host methylation signature , 5 years; Technology development , 5 years; Technology validation , 5 years. Brief summary: The purpose of this research study is to test a new process for diagnosing breast cancer by examining changes to your DNA that can be detected from a blood test. The information we learn by doing this study could potentially help people in the future. Participants in this study will have blood samples collected, have their medical records reviewed by study personnel and fill out questionnaires at different time points during the study. Blood sample collection will occur during normal routine clinic visits. Participation in this study will last approximately 5 years.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.