Breast CarcinomaNCT07207564
Integrating Molecular Pathology, Radiology, and Genetics to Improve Breast Cancer Risk
An observational study of Breast Carcinoma, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this research is to better understand how benign breast diseases might lead to breast cancer, focusing on genetic factors and including a diverse range of participants to improve future diagnosis and treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 4,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Aug 2025to 30 Jun 2030
- 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 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who had a benign breast biopsy at Mayo Clinic between 2002 and 2022.
Who may be able to join
- Female patients, ages 18 to 100 years
- Had a benign breast biopsy at Mayo Clinic between 2002-2022
Who cannot join
- All male patients
- Prior or concomitant diagnosis of BC
- Diagnosis of BC within six months of benign breast disease
- Denial of research authorization
- Concurrent or post-biopsy bilateral prophylactic mastectomy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Laura Pacheco-Spann, 904-953-0408, PachecoSpann.Laura@mayo.edu
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Laura Pacheco-Spann, 904-953-0408, pachecospann.laura@mayo.edu
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
About this study
The purpose of this research is to better understand how benign breast diseases might lead to breast cancer, focusing on genetic factors and including a diverse range of participants to improve future diagnosis and treatment.
- Conditions
- Breast Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Participants complete a questionnaire, undergo collection of saliva or blood samples, and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic features
Will examine pathologic features from benign tissue to define features related to breast cancer (BC) risk.
Measured: Baseline (collection of blood or saliva sample)
Radiologic features
Will examine radiologic features from mammographic images at time of benign breast disease (BBD) to define features in mammogram images that predict BC risk among women who have a history of BBD. We will also assess whether these features predict BC risk among women without a history of BBD.
Measured: Baseline (collection of blood or saliva sample)
Molecular features
Will examine molecular features to understand how molecular features, including DNA damage and repair work in the breast tissues of women with BBD and how this might relate to risk of developing BC
Measured: Baseline (collection of blood or saliva sample)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start28 Aug 2025
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark E. Sherman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207564
- Sponsor's protocol ID
- 23-009436
- Other IDs
- NCI-2025-06873, 23-009436, HT94252310234
- Status last verified
- Aug 2026
- First submitted
- 26 Sep 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Molecular Pathology, Radiology, and Genetics to Improve Breast Cancer Risk
- ClinicalTrials.gov ID
- NCT07207564
- Acronym / sponsor ID
- 23-009436
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 6 Oct 2025 (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 is to better understand how benign breast diseases might lead to breast cancer, focusing on genetic factors and including a diverse range of participants to improve future diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyParticipants complete a questionnaire, undergo collection of saliva or blood samples, and have their medical records reviewed on study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who had a benign breast biopsy at Mayo Clinic between 2002 and 2022.
Key inclusion criteria (2 listed)
- Female patients, ages 18 to 100 years
- Had a benign breast biopsy at Mayo Clinic between 2002-2022
Key exclusion criteria (5 listed)
- All male patients
- Prior or concomitant diagnosis of BC
- Diagnosis of BC within six months of benign breast disease
- Denial of research authorization
- Concurrent or post-biopsy bilateral prophylactic mastectomy
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 |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational |
Primary outcome
Pathologic features
Time frame: Baseline (collection of blood or saliva sample)
Will examine pathologic features from benign tissue to define features related to breast cancer (BC) risk.
Radiologic features
Time frame: Baseline (collection of blood or saliva sample)
Will examine radiologic features from mammographic images at time of benign breast disease (BBD) to define features in mammogram images that predict BC risk among women who have a history of BBD. We will also assess whether these features predict BC risk among women without a history of BBD.
Molecular features
Time frame: Baseline (collection of blood or saliva sample)
Will examine molecular features to understand how molecular features, including DNA damage and repair work in the breast tissues of women with BBD and how this might relate to risk of developing BC
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 27 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Carcinoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Mark E. Sherman, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by Mayo Clinic at 2 sites 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Laura Pacheco-Spann (904-953-0408, pachecospann.laura@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic features (time frame: Baseline (collection of blood or saliva sample)). 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?
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 27 Aug 2026.