Status:
TERMINATED
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
Lead Sponsor:
Biocept, Inc.
Collaborating Sponsors:
ICON plc
Conditions:
Leptomeningeal Metastasis
Leptomeningeal Disease
Eligibility:
All Genders
Brief Summary
The FORESEE Study is a multi-center, prospective clinical trial enrolling patients with Breast or Non-Small Cell Lung Cancer (NSCLC) who have suspicious or confirmed Leptomeningeal Metastases (LM). St...
Detailed Description
The FORESEE Study is a multi-center, prospective clinical trial enrolling patients with breast or Non-Small Cell Lung Cancer (NSCLC) who have suspicious or confirmed Leptomeningeal Metastases (LM). LM...
Eligibility Criteria
Inclusion
- Subjects =\> 18 years of age
- All genders, races, or ethnic groups,
- Diagnosed with Breast Cancer or NSCLC who present with clinically suspected LM based on Investigator assessment of radiographic image, cytology, and clinical evaluation.
- Cytology positive and negative subjects will be included.
- Subjects willing to provide an Informed Consent.
- Subjects willing and able to undergo CSF or blood collection via Lumbar Puncture and Ommaya Reservoir as well as veni-puncture and shunt.
- Both patients with and without parenchymal brain metastases will be eligible as long as leptomeningeal metastases are suspected
- Subjects who previously had a diagnosis of Leptomeningeal Disease by Investigator assessment of radiographic image and clinical evaluation and cytology.
Exclusion
- Subjects who do not have cancer,
- Subjects with other types of tumors than breast or lung cancer
- Subjects diagnosed with a primary brain tumor
- Subjects who are unable to undergo lumbar puncture, a shunt or veni-puncture.
- Lack of suspicious LM based in imaging or clinical evaluation.
- Ordering the Commercial CNSide test while subject is on study
- Pregnant women and adults lacking capacity to consent for themselves
Key Trial Info
Start Date :
September 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 13 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05414123
Start Date
September 7 2022
End Date
October 13 2023
Last Update
October 16 2023
Active Locations (4)
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1
Stanford University
Stanford, California, United States, 94305
2
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
3
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235-1979
4
University of Washington
Seattle, Washington, United States, 98109