Ignite Creation Date:
2024-05-06 @ 5:44 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05414123
Status:
TERMINATED
Last Update Posted:
2023-10-16
First Post:
2022-06-08
Brief Title:
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases LM Using CNSide
Sponsor:
Biocept Inc
Organization:
Biocept Inc
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor can no longer financially support the trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FORESEE
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 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 Physicians discretion in Biocepts 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 LMs response to treatment and to assess the impact of CNSide on treatment decisions made by Physicians
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 is a devastating complication of breast cancer and NSCLC and is diagnosed via clinical evaluation MRI with and without contrast of the brain and spine and CSF Cytology These methods have limited sensitivity and specificity Furthermore they lack the ability to quantitatively measure the LMs response to treatment These hindrances create challenges for physicians to manage LM or to determine the best course of treatment CNSide is a Laboratory Developed Test LDT that is analytically validated and run commercially in Biocepts CLIA certified CAP accredited laboratory at the Physicians discretion CNSide can detect and quantify tumor cells in the CSF from patients with Breast Cancer or NSCLC having a suspicious or confirmed LM Data derived from case studies suggest that the detection of tumor cells in the CSF by CNSide can be used by Physicians to monitor the response of the LM tumor to treatment and improve the ability to make treatment decisions in patients with LM Subjects enrolled onto the trial will be treated per Standard of Care The diagnostic tests used to either diagnose LM or monitor the LMs response to treatment will be Standard of Care in combination with CNSide The goal of the FORESEE Study is to further evaluate the performance of CNSide for LM in monitoring the LMs response to treatment and to assess the impact of CNSide on treatment decisions made by Physicians
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None