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Not yet recruiting NCT07219199

Residual IDH1-Mutant Tumor Cell Quantification Study

No phase Interventional Glioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UR-ddPCR.
Who it may be relevant to
Registry conditions: Glioma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Intraoperative Quantification of Residual IDH1-mutant Tumor Cells Via Ultra-Rapid Droplet Digital PCR

Overview

This is a single-site, single-arm, prospective, interventional cohort study using intraoperative ultra-rapid droplet digital polymerase chain reaction (UR- ddPCR) to assess residual IDH1-mutant tumor at the end of surgical resection and, if positive, guide additional resection in real-time.

Interventions

  • Device UR-ddPCR
    The investigational UR-ddPCR assay will be performed on collected tissue specimens during the participant's scheduled surgical visit.

Primary outcome measures

  • Progression-Free Survival (PFS) [Time frame: Up to Year 3 Post-Procedure]
Secondary outcome measures (5)
  • Overall Survival (OS) [Time frame: Up to Year 3 Post-Procedure]
  • Residual Tumor Volume [Time frame: Postoperative Day 1 (POD1)]
  • Radiographic PFS [Time frame: Month 6 Post-Procedure, Month 12 Post-Procedure, Month 24 Post-Procedure, Month 36 Post-Procedure]
  • Time to Radiographic Recurrence [Time frame: Up to Year 3 Post-Procedure]
  • Percent Change in Mutant Allele Fraction (MAF) [Time frame: Post-Operative Day 0 (POD0), post-additional resection of tumor-brain interface samples (Up to Year 3)]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years at the time of consent (any sex)
  • Newly diagnosed diffuse glioma with either (a) radiographic features consistent with IDH-mutant glioma or (b) prior molecular confirmation of an IDH mutation
  • Scheduled for tumor tissue biopsy or surgical resection at NYU Langone Health

Exclusion criteria

  • Active hepatitis C virus (HCV) infection or suspected/confirmed prion disease (e.g., Creutzfeldt-Jakob disease), as documented in the medical record or by the treating physician, due to biosafety and tissue- handling restrictions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07219199 · Pending-IDE G250266

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗