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Natural History of and Specimen Banking for People With Tumors of the Central Nervous System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02851706
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date July 29, 2016
First Posted Date August 2, 2016
Last Update Posted Date February 13, 2020
Actual Study Start Date September 1, 2016
Estimated Primary Completion Date June 6, 2066   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 8, 2018)
To evaluate patients with tumors of the central nervous system (CNS) who are probable future candidates for NCI Phase I and II protocols [ Time Frame: completion of study ]
Generalized knowledge about CNS tumors
Original Primary Outcome Measures
 (submitted: July 29, 2016)
To evaluate patients with tumors of the central nervous system (CNS) who are probable future candidates for NCI Phase I and II protocols [ Time Frame: completion of study ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: July 29, 2016)
  • To follow patients with tumors of the CNS that are representative ofimportant scientific and/or clinical principles [ Time Frame: completion of study ]
  • To follow patients with CNS tumors that are understudied or haveindeterminate natural history [ Time Frame: completion of study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Natural History of and Specimen Banking for People With Tumors of the Central Nervous System
Official Title Evaluation of the Natural History of and Specimen Banking for Patients With Tumors of the Central Nervous System
Brief Summary

Background:

Brain and spinal cord tumors are uncommon. But they contribute substantially to cancer deaths in the U.S. in children and adults. Little progress has been made in treating brain tumors. Researchers want to learn more about these tumors by studying people who have them.

Objectives:

To understand brain and spinal cord tumors better and uncover areas for further research. Also, to connect people with these tumors to doctors who can help them manage their illness and give them new treatment options.

Design:

Participants will have an initial (baseline) visit. They will have their medical history taken and undergo physical and neurological exams. They will have blood tests. They may have scans (imaging studies) of the nervous system.

If participants have urine or cerebrospinal fluid collected during their regular care, researchers may save some.

Brain tumor tissue from a prior surgery may be studied.

Genomic DNA testing will be done on samples. Results will be linked to participants medical and/or family history.

The number of study visits at NIH will depend on the wishes of participants and their local doctors.

Participants will take a brain tumor survey on a computer. They can take it all at once or in 6 separate sections.

Participants will answer questions about their general well-being. They will answer questions to learn if they have symptoms of depression or anxiety.

Physicians will discuss test results with participants. They will recommend management and treatment options.

Detailed Description

Background:

This protocol is designed to meet an unmet need in neuro-oncology by evaluating patients with CNS tumors throughout their disease course. The protocol will evaluate patients with tumors of the central nervous system (CNS) who appear to be probable candidates for future protocol entry, have disease manifestations that are of unique scientific interest, importance, and/or educational value, or who have understudied tumors with unknown or unclear natural history. Patients with known genetic syndromes at high risk of developing CNS cancers will also be evaluated.

Objectives:

  • To evaluate patients with tumors of the central nervous system (CNS) who are probable future candidates for NCI Phase I and II protocols
  • To follow patients with tumors of the CNS that are representative of important scientific and/or clinical principles
  • To follow patients with CNS tumors that are understudied or have indeterminate natural history
  • To evaluate and follow patients with known genetic syndromes at high risk of developing CNS cancers

Eligibility:

  • All patients greater than or equal to 18 years of age with tumors of the CNS (or a history of tumors of the CNS) of interest to the NOB, who may be candidates for an NOB trial at some point in the future.
  • Patients with tumors of the CNS that are of particular interest to members of the NOB because they pose important clinical and/or scientific questions and/or shed light on important aspects of the disease.
  • Patients with known genetic syndromes at high risk of developing CNS cancers are eligible.
  • Patients with rare tumors of the CNS who offer an important educational benefit to neuro-oncology trainees and staff.
  • Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

Design:

  • All patients will undergo an initial evaluation at the Clinical Center by a member of the NOB where past medical and oncologic histories will be obtained as well as relevant data such as neuroimaging and pathology review. A total of 10,000 patients will be accrued to this study.
  • Patients may be seen at the NIH Clinical Center at varying intervals depending on the clinical situation. Data related to the natural history of their disease course and outcome will be collected at least every visit at the NIH Clinical Center in which imaging is reviewed. Patients will be see at a clinic visit or followed remotely at a minimum of once every year.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with CNS Tumors and patients with known genetic syndromes at high risk of developing CNS cancers@@@
Condition
  • Brain Cancer
  • Brain Tumor
  • Spine Cancer
  • Spine Tumor
  • Neoplasm
Intervention Not Provided
Study Groups/Cohorts 1-Patients with CNS Tumors
Patients with CNS tumors (or a history) including those with undiagnosed imaging abnormalities in the CNS; and patients with known genetic syndromes at high risk of developing CNS Cancers.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 29, 2016)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 5, 2100
Estimated Primary Completion Date June 6, 2066   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • INCLUSION CRITERIA:
  • All patients greater than or equal to 18 years of age with tumors of the CNS (or a history of tumors of the CNS) of interest to the NOB who may be future candidates for another NOB trial. This includes patients with undiagnosed imaging abnormalities in the central nervous system (brain and/or spinal cord): and patients with known genetic syndromes at high risk of developing CNS Cancers.
  • Patients with tumors of the CNS that are of particular interest to members of the NOB because they pose important clinical and/or scientific questions and/or shed light on important aspects of the disease.
  • Patients with rare tumors of the CNS (defined as occurring in less than 1,000 patients/year in the United States) who offer an important educational benefit to neurooncology trainees and staff.
  • Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

-Patients who are seen for a second opinion only and who do not plan to return to the NIH for clinical evaluation or care.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sonja K Crandon, R.N. (240) 760-6099 sonja.crandon@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02851706
Other Study ID Numbers 160151
16-C-0151
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor National Cancer Institute (NCI)
Collaborators Not Provided
Investigators
Principal Investigator: Terri S Armstrong, C.R.N.P. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date February 11, 2020