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A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide (FORESEE)

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ClinicalTrials.gov Identifier: NCT05414123
Recruitment Status : Recruiting
First Posted : June 10, 2022
Last Update Posted : September 9, 2022
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
Biocept, Inc.

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.

Condition or disease Intervention/treatment
Leptomeningeal Metastasis Leptomeningeal Disease Leptomeningeal Neoplasms Breast Cancer Non-Small Cell Lung Cancer Device: CNSide

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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).
Actual Study Start Date : September 7, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : January 1, 2025

Group/Cohort Intervention/treatment
Breast Cancer
Subjects with Breast Cancer of all subtypes and independent of Hormone status who have a confirmed or suspicious Leptomeningeal Metastasis by Investigator assessment of radiographic image and clinical evaluation and cytology
Device: CNSide
The Cerebro-Spinal Fluid (CSF) of subjects enrolled into each cohort will be used for Standard of Care diagnostic assessments used for subjects with either confirmed or suspicious LM (Cytology, protein and glucose) in combination with CNSide analysis.

Non-Small Cell Lung Cancer
Subjects with Non-Small Cell Lung Cancer of all subtypes who have a confirmed or suspicious Leptomeningeal Metastasis by Investigator assessment of radiographic image and clinical evaluation and cytology
Device: CNSide
The Cerebro-Spinal Fluid (CSF) of subjects enrolled into each cohort will be used for Standard of Care diagnostic assessments used for subjects with either confirmed or suspicious LM (Cytology, protein and glucose) in combination with CNSide analysis.




Primary Outcome Measures :
  1. Assess the impact of CNSide on treatment decisions [ Time Frame: 1 year ]
    The proportion of decision points during LM treatment in which the physician indicated that CNSide aided in their decision making.


Secondary Outcome Measures :
  1. Evaluate CNSide as a treatment response monitoring device for LM tumors [ Time Frame: 2 years ]
    The correlation of changes in tumor cell number throughout treatment with clinical evaluation, cytology, and radiographic results.

  2. The performance of CNSide of tumor cell detection in the CSF compared to cytology [ Time Frame: 2 years ]
    The comparison of the sensitivity, specificity, PPV and NPV of CNSide to cytology in detection of tumor cells in the CSF (Cytology being the reference standard)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05414123


Contacts
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Contact: Barbara Blouw, PhD 858-320-8200 ext 208 bblouw@biocept.com
Contact: David Isley, PhD 858-223-0649 ext 374 disley@biocept.com

Locations
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United States, California
Valkyrie Clinical Trials Recruiting
Los Angeles, California, United States, 90067
Contact: Myo O Zaw, M.B, B.S    424-296-1891    myo.zaw@valkyrieclinicaltrials.com   
Contact: Olachi N Opara, RN, FNP    424-296-1891    olachi@valkyrieclinicaltrials.com   
Principal Investigator: David Berz, MD, PhD, MPH         
Sub-Investigator: Olachi N Opara, RN, FNP         
Sponsors and Collaborators
Biocept, Inc.
ICON plc
Investigators
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Principal Investigator: Priya Kumthekar, MD Northwestern University Medical Center
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Responsible Party: Biocept, Inc.
ClinicalTrials.gov Identifier: NCT05414123    
Other Study ID Numbers: BIOC-046
First Posted: June 10, 2022    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make the IDP available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Biocept, Inc.:
Leptomeningeal Metastasis
Cerebro-Spinal Fluid
Liquid Biopsy
Tumor Cells
Additional relevant MeSH terms:
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Neoplasm Metastasis
Meningeal Carcinomatosis
Meningeal Neoplasms
Neoplasms by Site
Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases