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

• ClinicalTrials.gov Identifier: NCT02851706
• Recruitment Status: Recruiting
• First Posted: August 2, 2016
• Last Update Posted: March 23, 2023
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Description

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 by a member of the NOB or by a health care provider participating in the patient s care, 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 seen at a clinic visit or followed remotely at a minimum of once every year.

Study Design

• 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
• Actual Study Start Date: September 1, 2016
• Estimated Primary Completion Date: June 6, 2066
• Estimated Study Completion Date: April 5, 2100

Groups and Cohorts

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.

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Patients with CNS Tumors and patients with known genetic syndromes at high risk of developing CNS cancers

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.

EXECLUSION CRITERIA:

None

Contacts and Locations

Contacts

Contact: NCI NOB Referral Group; (866) 251-9686; ncinobreferrals@mail.nih.gov

Contact: Terri S Armstrong, C.R.N.P.; (240) 760-6003; terri.armstrong@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)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT02851706
• Other Study ID Numbers: 160151; 16-C-0151
• First Posted: August 2, 2016
• Last Update Posted: March 23, 2023
• Last Verified: February 10, 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: .BTRIS: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@dbGaP: All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: BTRIS: Clinical data available during the study and indefinitely.@@@@@@dbGaP: Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: BTRIS: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@dbGaP: Genomic data are made available via dbGaP through requests to the data custodians.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):

Brain Tumor; Glioma; Astrocytoma; Brain Cancer; Spine Cancer; Natural History

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