Demographics, Characteristics and Outcomes of Male Breast Cancer Patients at Methodist Health System

• Sponsor: Methodist Health System (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06133647
• Collaborator: (none)
• Enrollment: 8
• Locations: 2
• Anticipated Duration (Months): 12
• Patients Per Site: 4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

To determine the number of MBC cases as well as the demographics, characteristics, and outcomes of MBC patients at Methodist Health System (MHS).

Condition or Disease	Intervention/Treatment	Phase
Male Breast Cancer Patients	Procedure: managing Male Breast Cancer Patients at Methodist Health System

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

• Study Type: Observational
• Anticipated Enrollment: 8 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Demographics, Characteristics and Outcomes of Male Breast Cancer Patients at Methodist Health System
• Actual Study Start Date: May 4, 2023
• Anticipated Primary Completion Date: May 4, 2024
• Anticipated Study Completion Date: May 4, 2024

Outcome Measures

Primary Outcome Measures

1. Diagnosis Rates of patients with MBC and FBC [13 years]

   complications of treatment

2. Recurrence rates of Patients with MBC and FBC [13 years]

   Recurrence rates of Patients with MBC and FBC

3. Duration of remission in Patients with MBC and FBC [13 years]

   Duration of remission in Patients with MBC and FBC

4. The Overall Survival of patients with MBC and FBC after receiving treatment [13 years]

   The Overall Survival of patients with MBC and FBC after receiving treatment

5. Determine the complications of Treatment in patients with MBC and FBC [13 years]

   Determine the complications of Treatment in patients with MBC and FBC

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• • ≥ 18 years of age Patients diagnosed with ductal carcinoma in situ or invasive lobular carcinoma of the breast

Exclusion Criteria:

• 18 years of age

• Prisoners

• Pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Institute at Methodist Health System	Dallas	Texas	United States	75203
2	Clinical Research Institute at Methodist Health System	Dallas	Texas	United States	75203

Sponsors and Collaborators

• Methodist Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Methodist Health System
• ClinicalTrials.gov Identifier: NCT06133647
• Other Study ID Numbers: 015.MTP.2023.A
• First Posted: Nov 15, 2023
• Last Update Posted: Nov 15, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Breast Neoplasms, Male

Study Results

No Results Posted as of Nov 15, 2023