Clinical trial · Observational
Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
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 (Locally Advanced or Metastatic) | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
| Breast Cancer Screening | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Healthy Volunteers (HV) | — | UNRESOLVED | — |
| Unhealthy Volunteers | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epigenetic Assay | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Study Population 1
- description
- This study population will consist of individuals who have a diagnosis of breast cancer and have not received chemotherapy treatment for their breast cancer. Individuals who have received surgical resection and/or radiation therapy and/or endocrine therapy for their breast cancer will be included.
- interventionNames
- Other: Epigenetic Assay
- label
- Study Population 2
- description
- This study population will consist of individuals who have a diagnosis of breast cancer and have received chemotherapy treatment for their breast cancer. All stages of breast cancer will be included including individuals in remission.
- interventionNames
- Other: Epigenetic Assay
- label
- Study Population 3
- description
- This study population will consist of individuals who are at high risk of developing breast cancer.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years old or older * Patient of UMMS * Willing and able to consent to study procedures listed in the protocol * Ability to speak and understand English Exclusion Criteria: * Younger than 18 years old * Patient not cared for at UMMS * Unable to consent to study procedures listed in the protocol * Unable to speak or understand English
References
Publications (1)
- BACKGROUNDLi Y, Fan Z, Meng Y, Liu S, Zhan H. Blood-based DNA methylation signatures in cancer: A systematic review. Biochim Biophys Acta Mol Basis Dis. 2023 Jan 1;1869(1):166583. doi: 10.1016/j.bbadis.2022.166583. Epub 2022 Oct 18. PMID 36270476