Status:
NOT_YET_RECRUITING
Residual IDH1-Mutant Tumor Cell Quantification Study
Lead Sponsor:
NYU Langone Health
Conditions:
Glioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT07219199
Start Date
December 1 2025
End Date
December 1 2030
Last Update
October 21 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016