Neoplasms

Nervous System Diseases

All Conditions

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Archived CNS neoplasm specimens, in which primary diagnostic studies are complete, and for which there is excess tissue for analysis in the form of unstained slides or paraffin blocks

Terri S Armstrong, C.R.N.P.

Background:

The number of people who get tumors of the brain or central nervous system (CNS) is lower than other cancers. But these tumors cause a higher rate of serious effects and even death. Researchers want to test existing samples of tissue from these tumors to learn more about them. This may lead to better treatment.

Objective:

To study stored samples of CNS tumors to learn more about the tumors and explore new ways to diagnose them.

Eligibility:

The study will use tissue samples already collected at NIH from people with brain or CNS tumors.

Design:

The participants will have given their consent in a previous study.

Researchers will review the tissue samples and any data collected about them.

Researchers will do lab tests and scans on the samples.

All data will be kept secure.

BACKGROUND

* Central Nervous System (CNS) and brain tumors are a heterogeneous group of neoplasms. They can be broadly categorized to tumors of neuroepithelial tissue, meninges, hematopoietic system, germ cells, and sella.
* The Central Brain Tumor Registry of the United States reports an overall average annual age-adjusted incidence rate for the years 2006-2010 for primary brain and CNS tumors as 21.03 per 100,000. This leads to an estimated mortality of over 13,000 deaths per year. Although this number is small compared to other more common cancers, due to the location of CNS (brain and spinal cord) tumors, they are responsible for disproportionately high morbidity and mortality among cancer patients.
* Although much progress has been made on overall understanding of CNS tumors, not much is known about mechanisms responsible for intratumoral heterogeneity, disease relapse, progression into higher grades, and in vivo invasive mechanisms. This may involve new mutations, selection of specific clones of cells by either therapeutic pressure or as part of natural tumor evolution leading to progression, microenvironmental cues or combinations.
* This study will review the molecular pathological alterations of archived human CNS tumor specimens at initial presentation and at subsequent relapse. We will request archived brain tumor tissue samples from the NCI CCR Laboratory of Pathology at multiple time points to determine the expression of cellular proteins and surrogate markers involved in growth, proliferation, differentiation, invasion, and survival of brain tumor cells. Such information will be pooled with imaging data (MRI, PET, etc.) to identify potential surrogate markers of disease resistance.
* This study has the potential to uncover key molecular events underlying disease progression and thereby contribute to the understanding of CNS tumor pathogenesis without active patient intervention.

OBJECTIVES

-To study archived specimens of CNS tumors from the NCI CCR Laboratory of Pathology to explore potential new biomarkers for diagnosis and to better understand CNS tumor pathogenesis.

ELIGIBILITY

* Diagnosis of CNS neoplasm.
* Eligible cases include those in which primary diagnostic studies are complete, and for which there is excess tissue for analysis in the form of unstained slides or paraffin blocks archived in the NCI CCR Laboratory of Pathology as well as imaging stored in the NIH medical records system.
* We also request permission to extend this analysis, as may be relevant in the future, to surplus materials to be accrued under existing NCI protocols, upon completion of all superseding diagnostic tests and medical/scientific studies.

DESIGN

* We anticipate obtaining approximately 500 archived specimens in the NCI CCR Laboratory of Pathology from patients with CNS neoplasms to analyze parameters in order to better understand the biology and pathogenesis of disease.
* To identify potential specimens, medical records of patients seen in the Neuro-Oncology and Neurosurgery Clinics will be reviewed. Additional medical records will be reviewed in order to identify archived specimens and to obtain ancillary information such as result of imaging studies.
* Existing biomarker data will be analyzed in conjunction with review of histological features and clinical data existing in laboratory and imaging data to arrive at improved criteria for diagnosis, and to recognize newly identified, as yet undescribed, disease entities. New biomarkers, as they may become available, will be utilized to improve on current diagnostic methods for disease definition.
* Tissue may be collected from pathology to be processed for specific research question at a future time point. Time of processing may be contingent on accumulating sufficient number of specimens.

Biomarker Analysis of Central Nervous System Tumors

To study archived specimens of CNS tumors from the NCI CCR Laboratory of Pathology to explore potential new biomarkers for diagnosis and to better understand CNS tumor pathogenesis.

National Cancer Institute (NCI)

Symptoms and General Pathology

Rare Diseases

Recurrence

Glioblastoma

Glioma

Disease Attributes

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Photosensitizing Agents

Fluorescent substance to help visualize and remove as much tumor as possible without harming healthy tissue.

20 mg/kg administered once 3-5 hours prior to surgery

5-ALA (Gliolan)

Costas Hadjipanayis, MD, PhD

The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light. This may make it easier for your doctor to take out all of the tumor from your brain. The purpose of this study is to:

* Make sure that 5-ALA helps the doctor remove more of the tumor.
* Make sure 5-ALA does not cause any side effects.

If you do not want to participate in this study, your doctor(s) will still do their best to remove all of the tumor in your brain. Whether or not you join this study will not change your treatment for your brain tumor.

More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery

A Multicenter Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas

NX PharmaGen

Constantinos Hadjipanayis

Professor and Chair, Neurosurgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biomarker Analysis of Central Nervous System Tumors	NCT02692898	Central Nervous... Primary Brain N... Neoplasms, Brai... Cancer of the B... Brain Cancer		- 99 Years	National Institutes of Health Clinical Center (CC)
Biomarker Analysis of Central Nervous System Tumors	NCT02692898	Central Nervous... Primary Brain N... Neoplasms, Brai... Cancer of the B... Brain Cancer		- 99 Years	National Institutes of Health Clinical Center (CC)
More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery	NCT01445691	Benign Neoplasm... Brain Cancer Brain Neoplasms... Brain Neoplasms... Brain Tumor, Pr... Brain Tumor, Re... Brain Tumors Intracranial Ne... Neoplasms, Brai... Neoplasms, Intr... Primary Brain N... Primary Maligna... Primary Maligna... Gliomas Glioblastoma	5-ALA (Gliolan)	18 Years - 80 Years	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for primary brain neoplasms