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A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
Trial ID: NCT05414123
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.
A Longitudinal Therapy Response Monitoring Study in Subjects With Leptomeningeal Metastases Using CNSide (CSF Tumor Cells) Compared to Standard of Care (CSF Cytology, Clinical Evaluation, and Imaging).
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.
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
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