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Personalized Trial in ctDNA-level-relapse Glioblastoma

NCT05539339 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-09-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Henan Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Xingyao Bu, MD, PhD · Henan Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-06-01
Completion
2025-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05539339 on ClinicalTrials.gov