A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide (NCT05414123) | Clinical Trial Compass
TerminatedNot Applicable
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
Stopped: The sponsor can no longer financially support the trial.
United States40 participantsStarted 2022-09-07
Plain-language 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). 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.
Who can participate
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Subjects who do not have cancer,
✕. Subjects with other types of tumors than breast or lung cancer
What they're measuring
1
Assess the impact of CNSide on treatment decisions