NCT05539339

Personalized Trial in ctDNA-level-relapse Glioblastoma

Molecular Profiling of Tumor in Situ Fluid in Guiding Individualized Treatment Plan in Adults With ctDNA-level-relapse Glioblastoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Henan Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Tumor in situ fluid (TISF) refers to the fluid within the surgical cavity of patients with glioblastoma. Postoperative serial TISF is collected for circulating tumor DNA (ctDNA) analysis and identifying ctDNA-level relapse driven by one or a set of specific genomic alterations before overt imaging recurrence of the tumor. This single-arm open-label prospective pilot feasibility trial recruiting 20 adult patients with ctDNA-level-relapse glioblastoma who are assigned to receive the personalized study treatment based on the genetic profile of their serial TISF ctDNA. It will be aimed to test whether the personalized intervention can prolong the progression-free and overall survival and the feasibility of conducting a full-scale trial.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
OTHER	Individualized intervention based on genomic alterations	Specialized tumor board recommended agents that target the specific recurrence-driving genomic alterations that are determined by serial TISF ctDNA analysis.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2022-09-14
• Last updated: 2022-09-27

Locations

1 site across 1 country: China