RECRUITING

Study in Patients With Breast Cancer Leptomeningeal Metastasis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study

Quick Facts

Study Start:2024-11-25
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06638294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, aged 18 or older
  2. * History of breast cancer (any subtype)
  3. * Suspected breast cancer-related leptomeningeal metastasis (i.e., by clinical signs or symptoms (i.e., peri-oral dysesthesia, unexplained new neurological symptoms in the absence of brain metastasis), radiographic, or by cerebrospinal fluid analysis), whereby patient will be treated along an leptomeningeal disease paradigm.
  4. * Previous central nervous system metastasis (including leptomeningeal disease or brain metastasis) is eligible.
  5. * Eastern Cooperative Oncology Group (ECOG) score of ≤3 or Karnofsky performance status ≥60.
  1. * Suspected central nervous system recurrence of hematologic malignancy, lymphoma or other solid tumor
  2. * Not eligible for treatment of leptomeningeal disease.

Contacts and Locations

Study Contact

Hopkins Breast Trials
CONTACT
410-614-1361
HopkinsBreastTrials@jhmi.edu
Sidney Kimmel Cancer Center Clinical Research Office
CONTACT
410-955-8866
jhcccro@jhmi.edu

Principal Investigator

Cesar Santa-Maria, MD
PRINCIPAL_INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Locations (Sites)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Cesar Santa-Maria, MD, PRINCIPAL_INVESTIGATOR, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-25
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-11-25
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • breast cancer

Additional Relevant MeSH Terms

  • Leptomeningeal Metastasis of Breast Cancer