Biomarker Analysis of Central Nervous System Tumors
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Brain Cancer, Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 99 |
| Updated: | 3/24/2019 |
| Start Date: | February 25, 2016 |
| End Date: | November 10, 2025 |
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.
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.
- 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.
- ELIGIBILITY CRITERIA:
- 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. Cases will be drawn from specimens previously
submitted to the NCI CCR Laboratory of Pathology in consultation or from surplus
materials from existing protocols, upon completion of all superseding diagnostic tests
and medical/scientific studies in cases where the patient is deceased or has
previously consented to future use of samples on their original protocol consent.
Inclusion of additional NIH cases will be limited to those instances in which the
current informed consent encompasses the proposed analyses.
We found this trial at
1
site
9609 Medical Center Drive
Bethesda, Maryland 20892
Bethesda, Maryland 20892
1-800-422-6237
National Cancer Institute , 9000 Rockville Pike The National Cancer Institute (NCI) is part of...
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