NCT02692898

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

February 25, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 15, 2019

Enrollment Period

3.7 years

First QC Date

February 25, 2016

Last Update Submit

November 16, 2019

Conditions

Keywords

Brain TumorMolecular PathologyClinical DataImaging Data

Outcome Measures

Primary Outcomes (1)

  • Tumor profile of CNS 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.

    completion of study

Study Arms (1)

1

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

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain Neoplasms

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Terri S Armstrong, C.R.N.P.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2016

First Posted

February 26, 2016

Study Start

February 25, 2016

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

November 19, 2019

Record last verified: 2019-11-15

Locations