We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 637 for:    cyto therapeutics

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date June 8, 2022
First Posted Date June 10, 2022
Last Update Posted Date September 9, 2022
Actual Study Start Date September 7, 2022
Estimated Primary Completion Date July 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 9, 2022)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 9, 2022)
  • 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.
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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).
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Leptomeningeal Metastasis
  • Leptomeningeal Disease
  • Leptomeningeal Neoplasms
  • Breast Cancer
  • Non-Small Cell Lung Cancer
Intervention 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.
Study Groups/Cohorts
  • 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
    Intervention: Device: CNSide
  • 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
    Intervention: Device: CNSide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 9, 2022)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2025
Estimated Primary Completion Date July 1, 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Barbara Blouw, PhD 858-320-8200 ext 208 bblouw@biocept.com
Contact: David Isley, PhD 858-223-0649 ext 374 disley@biocept.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05414123
Other Study ID Numbers BIOC-046
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There is no plan to make the IDP available to other researchers.
Current Responsible Party Biocept, Inc.
Original Responsible Party Same as current
Current Study Sponsor Biocept, Inc.
Original Study Sponsor Same as current
Collaborators ICON plc
Investigators
Principal Investigator: Priya Kumthekar, MD Northwestern University Medical Center
PRS Account Biocept, Inc.
Verification Date September 2022