Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00899834
Study type Observational
Source St. Jude Children's Research Hospital
Contact
Status Completed
Phase N/A
Start date June 2006
Completion date August 2015

See also
  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
Terminated NCT00107471 - Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma Phase 1/Phase 2
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
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