Brain Tumors Clinical Trial
Official title:
Comprehensive Molecular Analysis of Tumor Samples Derived From Patients With Diffuse Brainstem Glioma - A Pilot Study
This multi-institutional study will prospectively collect tumor and constitutional tissue samples from patients with diffuse brainstem glioma and other types of brainstem gliomas either during therapy or at autopsy to perform an extensive analysis of genetic and molecular abnormalities in these tumors.
Since very little is known about the biology of diffuse brainstem glioma, the goal of this
protocol is to undertake a systematic analysis of DNA abnormalities, and of RNA and protein
expression in prospectively collected fresh-frozen and fixed tumor samples and correspondent
normal tissue from patients affected with this tumor.
OBJECTIVES:
- Perform genome-wide analysis of DNA gains and losses and RNA expression in tumor
samples and normal tissue from patients with diffuse brain stem glioma.
- Identify regions of genomic gain or loss using either array comparative genomic
hybridization or single nucleotide polymorphism arrays.
- Investigate genome-wide expression patterns of RNA derived from tumor samples and
normal tissue from these patients via Affymetrix gene expression profiling.
- Validate the results of the genome-wide analysis by conducting further evaluation of
candidate genes or by investigating the expression of relevant gene products at the RNA
and protein levels.
- Perform analysis of mutations in candidate tumor-suppressor genes and oncogenes
(including whole genome sequencing studies) using direct sequence analysis of tumor DNA
and confirm the tumor-specific nature of these mutations by analyzing the correspondent
constitutional DNA.
- Confirm genomic gains or losses identified by means of fluorescence in situ
hybridization (FISH) performed on tissue microarray using non-neoplastic brain tissue
from each patient as control when available.
- Explore protein expression patterns identified by immunohistochemistry or western blot
and compare them to normal brain stem tissue.
- To obtain a follow-up (questionnaire and/or telephone interview) after autopsy with
parent(s), legal guardian(s), or family members of research participants in the United
States to assess aspects associated with this procedure, including potential benefits
and drawbacks
;
Observational Model: Case-Only, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02846038 -
Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
|
||
Completed |
NCT02537106 -
A Comparison of the Effect of 1.5 Versus 3% NaCl on Brain Relaxation and Microcirculation
|
N/A | |
Completed |
NCT01951950 -
Nicardipine vs Esmolol Craniotomy Emergence
|
Phase 1 | |
Completed |
NCT01222780 -
To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer
|
Phase 1 | |
Completed |
NCT00873184 -
Study of Massage Therapy Within a Brain Tumor Setting
|
N/A | |
Active, not recruiting |
NCT01115777 -
Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-central Nervous System (Non-CNS) Malignancies
|
||
Completed |
NCT00003935 -
Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
|
Phase 1 | |
Completed |
NCT00724191 -
Evaluation of Human Brain Tumor Therapy Response by Magnetic Resonance (MR)
|
||
Recruiting |
NCT04128306 -
Brain Areas of Time-To-Contact Perception: an Awake Surgery Study
|
N/A | |
Recruiting |
NCT05202899 -
Effect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy
|
Phase 4 | |
Completed |
NCT00707343 -
[F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors
|
Phase 1 | |
Completed |
NCT00850278 -
Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors
|
N/A | |
Completed |
NCT00528437 -
Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors
|
Phase 2 | |
Terminated |
NCT00107471 -
Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma
|
Phase 1/Phase 2 | |
Completed |
NCT00187174 -
Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors
|
Phase 1 | |
Completed |
NCT00135876 -
Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
|
Phase 3 | |
Completed |
NCT00062478 -
Study of Karenitecin (BNP1350) in Patients With Brain Tumors
|
Phase 2 | |
Completed |
NCT00241670 -
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid
|
Phase 3 | |
Not yet recruiting |
NCT01445691 -
More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery
|
Phase 2 | |
Terminated |
NCT01018290 -
Navigated Transcranial Magnetic Stimulation in Tumor Surgery
|
N/A |