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Residual IDH1-Mutant Tumor Cell Quantification Study

NCT07219199 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-10-21

No results posted yet for this study

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 at the end of surgical resection and, if positive, guide additional resection in real-time.

Conditions

Interventions

DEVICE

UR-ddPCR

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

Sponsors & Collaborators

Principal Investigators

  • Daniel Orringer, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07219199 on ClinicalTrials.gov