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Not yet recruiting NCT07374796

Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Breast Cancer

— Observational Breast Cancer (Locally Advanced or Metastatic) Healthy Volunteers (HV) Unhealthy Volunteers Breast Cancer Screening

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Epigenetic Assay.
Who it may be relevant to
Registry conditions: Breast Cancer (Locally Advanced or Metastatic), Healthy Volunteers (HV), Unhealthy Volunteers, Breast Cancer Screening. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

This clinical testing protocol outlines the validation process for an epigenetic assay targeting host peripheral blood cell and the associated host DNA methylation signatures designed to diagnose breast cancer. The overall protocol process will involve three distinct stages representing three patient cohorts with up to 150 subjects per cohort across 3 populations of patients. Cohort one will act as signature development phase; cohort two will act as signature finalization phase; and cohort three will act as a validation cohort phase. Each cohort with include the following patient populations with up to 50 patients per population:

1. Breast cancer, NO chemotherapy. Includes patients treated with surgical resection and/or radiation therapy and/or endocrine therapy 2. Breast cancer who have received chemotherapy. Includes all stages including remission 3. At risk group (patients at increased risk for breast cancer followed in a high risk breast program)

Interventions

  • Other Epigenetic Assay
    Up to 15 ml of blood will be collected from each patient at various time points throughout their 5 years of participation. DNA extraction, bisulfite conversion and analysis of epigenetic markers through PCR or next-generation sequencing will be performed. An epigenetic signature assay will then be identified.

Primary outcome measures

  • Identification of tumor-associated host methylation signature [Time frame: 5 years]
  • Technology development [Time frame: 5 years]
  • Technology validation [Time frame: 5 years]
Secondary outcome measures (3)
  • EORTC QLQ-C30 Questionnaire [Time frame: 5 years]
  • EORTC QLQ-BR45 Questionnaire [Time frame: 5 years]
  • SF-36v2 Questionnaire [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Maryland Baltimore Washington Medical Center — Glen Burnie

Publications

  • Li 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

Identifiers

NCT: NCT07374796 · HP-00117656

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗