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

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ClinicalTrials.gov Identifier: NCT02851706
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.


Condition or disease
Brain Cancer Brain Tumor Spine Cancer Spine Tumor Neoplasm

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 and at a minimum of every year.

Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Natural History of and Specimen Banking for Patients With Tumors of the Central Nervous System
Study Start Date : July 29, 2016
Estimated Primary Completion Date : June 6, 2066
Estimated Study Completion Date : April 5, 2100

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with CNS Tumors
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851706


Contacts
Contact: Sonja K Crandon, R.N. (240) 760-6099 sonja.crandon@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Terri S Armstrong, C.R.N.P. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02851706     History of Changes
Other Study ID Numbers: 160151
16-C-0151
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 3, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Neoplasm
Brain Tumor
Glioma
Astrocytoma
Brain Cancer
Spine Cancer

Additional relevant MeSH terms:
Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases