NCT06133647

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

March 27, 2026

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

July 6, 2023

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Diagnosis Rates of patients with MBC and FBC

    complications of treatment

    13 years

  • Recurrence rates of Patients with MBC and FBC

    Recurrence rates of Patients with MBC and FBC

    13 years

  • Duration of remission in Patients with MBC and FBC

    Duration of remission in Patients with MBC and FBC

    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

    13 years

  • Determine the complications of Treatment in patients with MBC and FBC

    Determine the complications of Treatment in patients with MBC and FBC

    13 years

Interventions

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

Also known as: Larger studies in MBC are needed to provide more clinical data to help guide treatment.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • years of age
  • Prisoners
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Institute at Methodist Health System

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, NoninfiltratingCarcinoma, Lobular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryBreast NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

November 15, 2023

Study Start

May 4, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

March 27, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations