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Molecular Profiling

Molecular Profiling for Brain Tumor (PNOC008 Trial)

N/A
Waitlist Available
Led By Sabine Mueller, MD, PhD, MAS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≤ 21 years
Adequate neurologic function defined as: Patients with seizure disorder may be enrolled if seizures are well controlled.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

PNOC008 Trial Summary

This trial will test a new treatment approach for children with High-grade gliomas HGG that is based on each patient's tumor gene expression, whole-exome sequencing (WES), targeted panel profile (UCSF 500 gene panel), and RNA-Seq.

Who is the study for?
This trial is for children and young adults up to 21 years old with newly diagnosed high-grade gliomas (HGG), including those with specific genetic mutations but not DIPG. Participants must start radiation therapy within six weeks of diagnosis, have a certain level of physical function, and be able to give consent. Pregnant or breastfeeding individuals are excluded, as well as those on other clinical trials or with serious health issues that could affect participation.Check my eligibility
What is being tested?
The trial tests an individualized treatment plan based on each patient's tumor genetics using gene expression profiling and sequencing techniques. The goal is to see if tailoring the treatment according to the tumor's molecular characteristics can improve outcomes in pediatric patients with HGG.See study design
What are the potential side effects?
Since this trial involves creating personalized treatment plans based on molecular profiling rather than testing a specific drug, side effects will vary depending on the treatments chosen for each participant. However, potential side effects may include typical cancer therapy-related reactions such as nausea, fatigue, hair loss, increased risk of infection, and others.

PNOC008 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or younger.
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My seizures are under control.
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I started radiation therapy within 6 weeks after my cancer was first diagnosed.
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I have a high-grade glioma (HGG) that is newly diagnosed, and I've had a tissue sample taken.
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I can perform daily activities with some assistance or am wheelchair-bound but active.
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My cancer has enough tissue available for detailed genetic testing.
Select...
I started radiation therapy less than 3 weeks ago.

PNOC008 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
12 month Overall Survival (OS) for Stratum B
12 month Progression Free Survival (PFS) for Stratum A
Secondary outcome measures
Frequency of Adverse Events
Frequency of Serious Adverse Events

PNOC008 Trial Design

2Treatment groups
Experimental Treatment
Group I: Newly diagnosed HGG (Stratum A)Experimental Treatment1 Intervention
Children and young adults with newly diagnosed HGG receive an individualized treatment plan. Each treatment is different and depends on what the Specialized Tumor Board recommends depending on the molecular profile of the patient's tumor.
Group II: Diffuse midline HGG (Stratum B)Experimental Treatment1 Intervention
Children and young adults with diffuse midline high grade gliomas receive an individualized treatment plan. Each treatment is different and depends on what the Specialized Tumor Board recommends depending on the molecular profile of the patient's tumor.

Find a Location

Who is running the clinical trial?

The V Foundation for Cancer ResearchOTHER
18 Previous Clinical Trials
1,224 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,493 Previous Clinical Trials
11,931,752 Total Patients Enrolled
21 Trials studying Glioblastoma
4,077 Patients Enrolled for Glioblastoma
Pacific Pediatric Neuro-Oncology ConsortiumOTHER
14 Previous Clinical Trials
693 Total Patients Enrolled
4 Trials studying Glioblastoma
156 Patients Enrolled for Glioblastoma

Media Library

Specialized tumor board recommendation (Molecular Profiling) Clinical Trial Eligibility Overview. Trial Name: NCT03739372 — N/A
Glioblastoma Research Study Groups: Diffuse midline HGG (Stratum B), Newly diagnosed HGG (Stratum A)
Glioblastoma Clinical Trial 2023: Specialized tumor board recommendation Highlights & Side Effects. Trial Name: NCT03739372 — N/A
Specialized tumor board recommendation (Molecular Profiling) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03739372 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many facilities are carrying out this investigation?

"The research initiative is recruiting patients at Ann & Robert H. Lurie Children's Hospital of Chicago in the city of Chicago, Illinois; University of Utah located in Salt Lake City, Utah; and University of California, San Diego Rady Children's Hospital based in San Diego, California as well as 12 other medical sites."

Answered by AI

How many participants are included in this trial's enrollment?

"The recruitment goal of this medical trial is 44 individuals that meet the eligibility requirements. Sites where patients can sign up for participation include Ann & Robert H. Lurie Children's Hospital of Chicago and University of Utah, both based in the United States of America."

Answered by AI

Are there any available slots to participate in this experiment?

"As per clinicaltrials.gov, recruitment for this trial is still ongoing and the original posting was made on November 28th 2018 with a most recent update from August 9th 2022."

Answered by AI
~7 spots leftby Mar 2025