Clinical trial NCT05414123: A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
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).
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Leptomeningeal Metastasis
Leptomeningeal Disease
Leptomeningeal Neoplasms
Breast Cancer
Non-Small Cell Lung Cancer
Keywords: Leptomeningeal Metastasis
Cerebro-Spinal Fluid
Liquid Biopsy
Tumor Cells
Lead sponsor: Biocept, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2022-06-10
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects will be selected from all clinics where subjects having Breast Cancer or Non-Small Cell Lung Cancer having a suspicious or confirmed LM are being diagnosed or treated by Physicians.

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 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.

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 LM's 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 Biocept's CLIA certified, CAP accredited laboratory at the Physician's 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 LM's response to treatment and to assess the impact of CNSide on treatment decisions made by Physicians.

Eligibility criteria: 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

Primary outcomes:
measure: Assess the impact of CNSide on treatment decisions
timeFrame: 1 year
Secondary outcomes:
measure: Evaluate CNSide as a treatment response monitoring device for LM tumors
timeFrame: 2 years
measure: The performance of CNSide of tumor cell detection in the CSF compared to cytology
timeFrame: 2 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Northwestern University Medical Center
name: Priya Kumthekar, MD
role: PRINCIPAL_INVESTIGATOR
References: