Breast Cancer (Locally Advanced or Metastatic)NCT07374796
Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Breast Cancer
An observational study of Breast Cancer (Locally Advanced or Metastatic) and Healthy Volunteers (HV), run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer (Locally Advanced or Metastatic), Healthy Volunteers (HV), Unhealthy Volunteers
- What is being tested?
- Epigenetic Assay
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Feb 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants will be selected from patients being cared for across the University of Maryland Medical System
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Maryland Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
Peter Olivieri, MD, 410-553-8241, polivieri@umm.edu
Cynthia Drogula, MD
About this study
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.
Read the 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:
- Breast cancer, NO chemotherapy. Includes patients treated with surgical resection and/or radiation therapy and/or endocrine therapy
- Breast cancer who have received chemotherapy. Includes all stages including remission
- At risk group (patients at increased risk for breast cancer followed in a high risk breast program)
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Healthy Volunteers (HV), Unhealthy Volunteers, Breast Cancer Screening
- Being tested
- Epigenetic Assay
- Keywords
- Breast Cancer, Breast Cancer Screening, Healthy Volunteers, Unhealthy Volunteers
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epigenetic AssayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Population 1 | 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. Receives: Other: Epigenetic Assay | |
| Study Population 2 | 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. Receives: Other: Epigenetic Assay | |
| Study Population 3 | This study population will consist of individuals who are at high risk of developing breast cancer. Receives: Other: Epigenetic Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of tumor-associated host methylation signature
Genome-wide methylation profile of whole blood from lung cancer patients, pre-cancer patients, patients undergoing therapy, and control subjects.
Measured: 5 years
Technology development
The investigators will develop array-based assays using whole-blood samples, focused on disease-specific methylation sites to provide early diagnosis, prognosis, and therapeutic efficacy prediction.
Measured: 5 years
Technology validation
The investigators will validate identified blood-based circulating methylation signatures in patients with undiagnosed pulmonary nodules.
Measured: 5 years
Secondary outcomes (3)
EORTC QLQ-C30 Questionnaire
The European Organization for Research and Treatment of Cancer core quality of life questionnaire, (EORTC QLQ-C30) is a cancer-specific quality of life instrument designed to assess health-related quality of life of cancer patients and is intended to be supplemented by disease-specific questionnaires, such as the lung cancer specific module, the EORTC QLQ-LC13. The EORTC QLQ-C30 incorporates nine multi-item scales including five functional scales (Physical, Role, Cognitive, Emotional and Social Functioning); three symptom scales (Fatigue, Pain and Nausea/Vomiting); and a Global Health Status/QoL scale. Six single item scales are also included (Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea and Financial Difficulties). All of the scales and single-item measures range in score from 0 to 100. A higher score represents a higher level of symptom burden.
Measured: 5 years
EORTC QLQ-BR45 Questionnaire
EORTC QLQ-BR45 is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The QLQ-BR45 incorporates nine multi-item scales to assess body image, sexual functioning, breast satisfaction, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All of the scales and single item measures range in score from 0 to 100. A high score for the functional scales and functional single items represents a high/healthy level of functioning, whereas a high score for the symptom scales and symptom item represents a high level of symptomatology or problems.
Measured: 5 years
SF-36v2 Questionnaire
The short-form of 36 questions (SF-36v2) is a multipurpose, 36-item survey that measures eight domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health. Higher scores indicate better health status.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study startDec 2026 (estimated)
- Primary completionJan 2033 (estimated)
- Study completionFeb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer (Locally Advanced or Metastatic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- EPOCH Epigenetics, Inc
- Responsible party
- Principal investigator, Peter Olivieri, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374796
- Sponsor's protocol ID
- HP-00117656
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 36270476
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Breast Cancer
- ClinicalTrials.gov ID
- NCT07374796
- Acronym / sponsor ID
- HP-00117656
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Healthy Volunteers (HV), Unhealthy Volunteers, Breast Cancer Screening
- Keywords
- Breast Cancer, Breast Cancer Screening, Healthy Volunteers, Unhealthy Volunteers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- EPOCH Epigenetics, Inc
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jan 2033 (estimated)
- Study completion
- Feb 2033 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Breast cancer, NO chemotherapy. Includes patients treated with surgical resection and/or radiation therapy and/or endocrine therapy
- Breast cancer who have received chemotherapy. Includes all stages including remission
- At risk group (patients at increased risk for breast cancer followed in a high risk breast program)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Population 1 | – | Other: Epigenetic AssayThis 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. |
| Study Population 2 | – | Other: Epigenetic AssayThis 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. |
| Study Population 3 | – | Other: Epigenetic AssayThis study population will consist of individuals who are at high risk of developing breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from patients being cared for across the University of Maryland Medical System
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epigenetic AssayUp 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. | Other | Study Population 1, Study Population 2, Study Population 3 |
Primary outcome
Identification of tumor-associated host methylation signature
Time frame: 5 years
Genome-wide methylation profile of whole blood from lung cancer patients, pre-cancer patients, patients undergoing therapy, and control subjects.
Technology development
Time frame: 5 years
The investigators will develop array-based assays using whole-blood samples, focused on disease-specific methylation sites to provide early diagnosis, prognosis, and therapeutic efficacy prediction.
Technology validation
Time frame: 5 years
The investigators will validate identified blood-based circulating methylation signatures in patients with undiagnosed pulmonary nodules.
3 secondary outcomes
EORTC QLQ-C30 Questionnaire
Time frame: 5 years
EORTC QLQ-BR45 Questionnaire
Time frame: 5 years
SF-36v2 Questionnaire
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 36270476Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer (Locally Advanced or Metastatic) and Healthy Volunteers (HV), run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Emel, MA (410-553-8048, Jennifer.Emel@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of tumor-associated host methylation signature (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07374796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.