Ductal Carcinoma in SituNCT06133647
Demographics, Characteristics and Outcomes of Male Breast Cancer Patients at Methodist Health System
An observational study of Ductal Carcinoma in Situ and Invasive Lobular Breast Carcinoma, run by Methodist Health System at 1 site in United States.
Trial summary
To determine the number of MBC cases as well as the demographics, characteristics, and outcomes of MBC patients at Methodist Health System (MHS). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ductal Carcinoma in Situ, Invasive Lobular Breast Carcinoma
- What is being tested?
- managing Male Breast Cancer Patients at Methodist Health System
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2023to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- Adult, Older adult
Study population: * ≥ 18 years of age * Patients diagnosed with ductal carcinoma in situ or invasive lobular carcinoma of the breast
Who may be able to join
- • ≥ 18 years of age Patients diagnosed with ductal carcinoma in situ or invasive lobular carcinoma of the breast
Who cannot join
- 18 years of age
- Prisoners
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Institute at Methodist Health System
Dallas, Texas, 75203
About this study
To determine the number of MBC cases as well as the demographics, characteristics, and outcomes of MBC patients at Methodist Health System (MHS).
Read the detailed description
Male breast cancer (MBC) is a rare disease without sufficient clinical data supporting the management and treatment. The treatment of MBC arises from data extrapolated from female breast cancer (FBC). MBC has higher mortality than FBC. Previous studies have suggested differences between MBC and FBC; however, treatments remain the same for both. Larger studies in MBC are needed to provide more clinical data to help guide treatment.
- Being tested
- managing Male Breast Cancer Patients at Methodist Health System
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
managing Male Breast Cancer Patients at Methodist Health SystemProcedure or surgery
Also called Larger studies in MBC are needed to provide more clinical data to help guide treatment.
To determine the number of MBC cases as well as the demographics, characteristics, and outcomes of MBC patients at Methodist Health System (MHS).
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis Rates of patients with MBC and FBC
complications of treatment
Measured: 13 years
Recurrence rates of Patients with MBC and FBC
Recurrence rates of Patients with MBC and FBC
Measured: 13 years
Duration of remission in Patients with MBC and FBC
Duration of remission in Patients with MBC and FBC
Measured: 13 years
The Overall Survival of patients with MBC and FBC after receiving treatment
The Overall Survival of patients with MBC and FBC after receiving treatment
Measured: 13 years
Determine the complications of Treatment in patients with MBC and FBC
Determine the complications of Treatment in patients with MBC and FBC
Measured: 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start4 May 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Carcinoma in SituStudies 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
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133647
- Sponsor's protocol ID
- 015.MTP.2023.A
- Status last verified
- May 2025
- First submitted
- 6 Jul 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographics, Characteristics and Outcomes of Male Breast Cancer Patients at Methodist Health System
- ClinicalTrials.gov ID
- NCT06133647
- Acronym / sponsor ID
- 015.MTP.2023.A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 15 Nov 2023 (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.
To determine the number of MBC cases as well as the demographics, characteristics, and outcomes of MBC patients at Methodist Health System (MHS).
Detailed description
Male breast cancer (MBC) is a rare disease without sufficient clinical data supporting the management and treatment. The treatment of MBC arises from data extrapolated from female breast cancer (FBC). MBC has higher mortality than FBC. Previous studies have suggested differences between MBC and FBC; however, treatments remain the same for both. Larger studies in MBC are needed to provide more clinical data to help guide treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * ≥ 18 years of age * Patients diagnosed with ductal carcinoma in situ or invasive lobular carcinoma of the breast
Key inclusion criteria (1 listed)
- • ≥ 18 years of age Patients diagnosed with ductal carcinoma in situ or invasive lobular carcinoma of the breast
Key exclusion criteria (3 listed)
- 18 years of age
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 |
|---|---|---|
| managing Male Breast Cancer Patients at Methodist Health SystemAlso: Larger studies in MBC are needed to provide more clinical data to help guide treatment.To determine the number of MBC cases as well as the demographics, characteristics, and outcomes of MBC patients at Methodist Health System (MHS). | Procedure or surgery | – |
Primary outcome
Diagnosis Rates of patients with MBC and FBC
Time frame: 13 years
complications of treatment
Recurrence rates of Patients with MBC and FBC
Time frame: 13 years
Recurrence rates of Patients with MBC and FBC
Duration of remission in Patients with MBC and FBC
Time frame: 13 years
Duration of remission in Patients with MBC and FBC
The Overall Survival of patients with MBC and FBC after receiving treatment
Time frame: 13 years
The Overall Survival of patients with MBC and FBC after receiving treatment
Determine the complications of Treatment in patients with MBC and FBC
Time frame: 13 years
Determine the complications of Treatment in patients with MBC and FBC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Ductal Carcinoma in Situ and Invasive Lobular Breast Carcinoma, run by Methodist Health System 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 27 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis Rates of patients with MBC and FBC (time frame: 13 years). The study lists 5 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 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.