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New treatment option for Solid Tumor Malignancies
Official title CSF and Blood Plasma Liquid Biopsy in Patients With Metastatic Solid Tumours and CNS Metastases or no CNS Metastases
ClinicalTrials.gov ID: NCT07476781
What this study is testing
- What it's testing
- This is a prospective, single-centre feasibility study of CSF ctDNA conducted at the Sunnybrook Odette Cancer Centre (SOCC), Toronto, Canada, including multiple solid tumor, stratified into cohorts according to CNS disease involvement, including leptomeningeal disease (Cohort A), parenchymal brain metastases (Cohort B), and no evidence of CNS metastases (Cohort C).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosed with a metastatic solid tumour in one of the following scenarios:
- Patients in Cohort A will have previously untreated or progressing leptomeningeal metastatic disease (LMD) with or without parenchymal brain...
- Patients in Cohort B will have previously untreated or BrM but no evidence of LMD.
- Patients in Cohort C will have progressing extra-cranial metastatic disease with no LMD or BrM.
- Patient is suitable for lumbar puncture and/or has an Ommaya reservoir that is accessible for CSF collection.
You likely can't join if
- Inability to understand or unwillingness to provide written informed consent (language barriers are not exclusionary; the use of a translator is...
- Patients with contraindications to lumbar puncture (e.g., infection at the LP site, uncontrolled bleeding diathesis \> 1.5], severe thrombocytopenia...
See the full eligibility criteria
- Diagnosed with a metastatic solid tumour in one of the following scenarios:
- Patients in Cohort A will have previously untreated or progressing leptomeningeal metastatic disease (LMD) with or without parenchymal brain metastases (BrM).
- Patients in Cohort B will have previously untreated or BrM but no evidence of LMD.
- Patients in Cohort C will have progressing extra-cranial metastatic disease with no LMD or BrM.
- Patient is suitable for lumbar puncture and/or has an Ommaya reservoir that is accessible for CSF collection.
- Patient is eligible at any time point in their treatment course, including whether or not they have already started treatment for LMD. Considering the poor prognosis associated with LMD, rapid clinical deterioration...
- Patients with active brain metastases, defined as newly diagnosed and previously untreated lesions, or lesions that were previously treated and are now progressing.
- Patients who were previously enrolled in the study and had negative CSF biomarkers may be re-enrolled at a later time point (e.g., upon progression of CNS disease).
- Inability to understand or unwillingness to provide written informed consent (language barriers are not exclusionary; the use of a translator is permitted).
- Patients with contraindications to lumbar puncture (e.g., infection at the LP site, uncontrolled bleeding diathesis \> 1.5], severe thrombocytopenia [platelet count \<40,000/µL], use of anticoagulant or antiplatelet...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.