Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638294
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Study in Patients With Breast Cancer Leptomeningeal Metastasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis The BioLept Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BioLept
Brief Summary:
Traditional clinical trials in patients with breast cancer leptomeningeal disease LMD are challenging as patients often have a rapidly progressive course and prognosis is poor making meeting standard eligibility difficult Furthermore there is limited information about the biology of LMD The investigators thus propose a study that is as inclusive as possible which will allow the investigators to collect biospecimens and clinical outcomes to learn more about LMD biology but still potentially provide benefit for patients by providing patients rapid diagnostics and multi-disciplinary treatment recommendations
Detailed Description:
This is a prospective translational observational study for patients with breast cancer leptomeningeal disease LMD LMD is notoriously difficult to treat and prognosis is generally very poor with most patients typically succumbing to the disease within a few months of its diagnosis Conducting clinical trials is challenging for these reasons and there are limited data regarding biological processes of LMD The overarching goal of this study is to be as inclusive as possible to optimize and learn from patients with LMD The investigators propose a prospective observational study to establish 1 a translational collection protocol to comprehensively collect tissue blood and CNS samples and 2 a therapeutic management program utilizing the Johns Hopkins Molecular Tumor Board to provide multi-disciplinary treatment recommendations in a timely manner and 3 collect outcome data that can be correlated with biomarkers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None