Leptomeningeal MetastasisFORESEENCT05414123
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
An observational study of Leptomeningeal Metastasis and Leptomeningeal Disease, run by Biocept, Inc. at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leptomeningeal Metastasis, Leptomeningeal Disease, Leptomeningeal Neoplasms
- What is being tested?
- CNSide
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Sep 2022to 13 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subjects who do not have cancer,
- Subjects with other types of tumors than breast or lung cancer
- Subjects diagnosed with a primary brain tumor
- Subjects who are unable to undergo lumbar puncture, a shunt or veni-puncture.
- Lack of suspicious LM based in imaging or clinical evaluation.
- Ordering the Commercial CNSide test while subject is on study
- Pregnant women and adults lacking capacity to consent for themselves
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
The University of Texas Southwestern Medical Center
Dallas, Texas, 75235-1979
University of Washington
Seattle, Washington, 98109
Stanford University
Stanford, California, 94305
About this study
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).
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.
Read the 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.
- Conditions
- Leptomeningeal Metastasis, Leptomeningeal Disease, Leptomeningeal Neoplasms, Breast Cancer, Non-Small Cell Lung Cancer
- Being tested
- CNSide
- Keywords
- Leptomeningeal Metastasis, Cerebro-Spinal Fluid, Liquid Biopsy, Tumor Cells
- Medical subject headings
- Meningeal Carcinomatosis, Meningeal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNSideDevice
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: CNSide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the impact of CNSide on treatment decisions
The proportion of decision points during LM treatment in which the physician indicated that CNSide aided in their decision making.
Measured: 1 year
Secondary outcomes (2)
Evaluate CNSide as a treatment response monitoring device for LM tumors
The correlation of changes in tumor cell number throughout treatment with clinical evaluation, cytology, and radiographic results.
Measured: 2 years
The performance of CNSide of tumor cell detection in the CSF compared to cytology
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start7 Sep 2022
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Why it stopped: The sponsor can no longer financially support the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocept, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Priya Kumthekar, MD, Principal investigator, Northwestern University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414123
- Sponsor's protocol ID
- BIOC-046
- Acronym
- FORESEE
- Status last verified
- Oct 2023
- First submitted
- 8 Jun 2022
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make the IDP available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT05414123
- Acronym / sponsor ID
- FORESEE / BIOC-046
- Conditions
- Leptomeningeal Metastasis, Leptomeningeal Disease, Leptomeningeal Neoplasms, Breast Cancer, Non-Small Cell Lung Cancer
- Keywords
- Leptomeningeal Metastasis, Cerebro-Spinal Fluid, Liquid Biopsy, Tumor Cells
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The sponsor can no longer financially support the trial.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Biocept, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | – | Device: CNSideSubjects 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 |
| Non-Small Cell Lung Cancer | – | Device: CNSideSubjects 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- Subjects who do not have cancer,
- Subjects with other types of tumors than breast or lung cancer
- Subjects diagnosed with a primary brain tumor
- Subjects who are unable to undergo lumbar puncture, a shunt or veni-puncture.
- Lack of suspicious LM based in imaging or clinical evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNSideThe 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. | Device | Breast Cancer, Non-Small Cell Lung Cancer |
Primary outcome
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.
2 secondary outcomes
Evaluate CNSide as a treatment response monitoring device for LM tumors
Time frame: 2 years
The performance of CNSide of tumor cell detection in the CSF compared to cytology
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The sponsor can no longer financially support the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: No. There is no plan to make the IDP available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priya Kumthekar, MD principal investigator
Northwestern University Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leptomeningeal Metastasis and Leptomeningeal Disease, run by Biocept, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The sponsor can no longer financially support the trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the impact of CNSide on treatment decisions (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.