Clinical trial · Interventional
Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma
Evaluating the Role of Cerebrospinal Fluid (CSF) Cell-free DNA (cfDNA) as a Prognostic Biomarker in Glioblastoma
NCT05927610CI-TRIAL-00089976withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment has not yet been initiated
Summary
Brief summary (as posted)
The goal of this study is to determine the utility of cerebrospinal fluid (CSF) cell-free DNA (cfDNA) as a prognostic biomarker in glioblastoma (GBM).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lumber Puncture | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Cohort A will consist of newly diagnosed patients with Glioblastoma. Eligibility for enrollment prior to pathology diagnosis will be determined by a consensus diagnosis of high grade glioma based on clinical and radiographic evidence between neuroradiologist, neurosurgeon and study PI.
- interventionNames
- Diagnostic Test: Lumber Puncture
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- Cohort B will consist of patients with a histologically confirmed diagnosis of IDH WT glioblastoma.
- interventionNames
- Diagnostic Test: Lumber Puncture
Primary outcomes (1)
- measure
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Cohort A * Participants must be able to understand and be willing to sign a written informed consent document * Age ≥ 18 years * MRI with contrast-enhancing lesion concerning for high-grade glioma in absence of known systemic malignancy * Clinical consensus of presumed diagnosis of high grade glioma between (1) neuroradiology (2) neurosurgery; and (3) principal investigator * No prior tumor directed therapy * Planned radiation therapy for glioblastoma * Patients must be willing and able to tolerate MRI scans and/or CT scans w/ contrast * Patients must be willing to consent to MSK IRB#12-245 Cohort B * Participants must be able to understand and be willing to sign a written informed consent document * Age ≥ 18 years * Histologic confirmed glioblastoma (WHO grade IV), IDH wild type per IHC * No prior tumor-directed therapies except surgical resection or biopsy * Patients who have gliadel wafers placed during upfront surgery are excluded * Planned radiation therapy for glioblastoma * Patients must be willing and able to tolerate MRI scans and/or CT scans w/ contrast * Patients must be willing to consent to MSK IRB#12-245 Exclusion Criteria: Cohorts A and B * Any case for which there is a medical contraindication or safety concern regarding a lumbar puncture under standard medical guidelines at MSK * Refusal to undergo serial lumbar punctures
References
Publications (0)
Data not yet available
No reference posted for this study.