A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
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). Standard of Care methods to diagnose, or assess the treatment response of LM (Clinical Evaluation, MRI and Cytology) have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. CNSide, is a Laboratory Developed Test (LDT ) that is used commercially at the Physician's discretion in Biocept's CLIA certified, CAP accredited laboratory. CNSide can detect and quantify tumor cells in the CSF from patients with Breast Cancer or NSCLC having a suspicious or confirmed LM. The goal of the FORESEE Study is to evaluate the performance of CNSide in monitoring the LM's response to treatment and to assess the impact of CNSide on treatment decisions made by Physicians.
Checked against the public recordLast updated Oct 16, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Biocept, Inc.
- Interventions being studied
- Device: CNSide
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. Subjects =\> 18 years of age 2. All genders, races, or ethnic groups, 3. Diagnosed with Breast Cancer or NSCLC who present with clinically suspected LM based on Investigator assessment of radiographic image, cytology, and clinical evaluation. 4. Cytology positive and negative subjects will be included. 5. Subjects willing to provide an Informed Consent. 6. Subjects willing and able to undergo CSF or blood collection via Lumbar Puncture and Ommaya Reservoir as well as veni-puncture and shunt. 7. Both patients with and without parenchymal brain metastases will be eligible as long as leptomeningeal metastases are suspected 8. Subjects who previously had a diagnosis of Leptomeningeal Disease by Investigator assessment of radiographic image and clinical evaluation and cytology. Exclusion Criteria: 1. Subjects who do not have cancer, 2. Subjects with other types of tumors than breast or lung cancer 3. Subjects diagnosed with a primary brain tumor 4. Subjects who are unable to undergo lumbar puncture, a shunt or veni-puncture. 5. Lack of suspicious LM based in imaging or clinical evaluation. 6. Ordering the Commercial CNSide test while subject is on study 7. Pregnant women and adults lacking capacity to consent for themselves
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Stanford UniversityStanford, California
- Northwestern University Feinberg School of MedicineChicago, Illinois
- The University of Texas Southwestern Medical CenterDallas, Texas
- University of WashingtonSeattle, Washington
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 16, 2023. Always confirm current availability with the study team.