Natural History of and Specimen Banking for People With Tumors of the Central Nervous System (NCT02851706) | Clinical Trial Compass
CompletedNot Applicable
Natural History of and Specimen Banking for People With Tumors of the Central Nervous System
United States1,214 participantsStarted 2016-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Patients (Person with the Disease)
* All patients \>= 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 2,500 patients/year in the United States) 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.
* Caregivers (Informants)
* Participants must be able to speak and read in English
* Age \>= 18 years old
* Participant must be able to understand and willing to sign a written consent document
* Participants must be a caregiver for Natural History Study participants with the disease addressed above (Patients). Caregivers will be defined as anyone who patients identify as an unpaid close friend or family member who knows them well and who is involved with their day-to-day care.
EXCLUSION CRITERIA:
None
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this natural history study at NCI is focused on identifying future candidates for Phase I and II treatment trials, could enrolling in something like this help position me for early access to experimental treatments for my CNS tumor down the road?
2This study involves specimen banking — what exactly does that mean for me in terms of what tissue, blood, or other samples would be collected, and how would those samples be used?
3Because this trial is listed as completed, are there any active follow-on NCI Phase I or II CNS tumor trials that grew out of this study that might be relevant to my situation?
4Since this is a natural history study rather than a treatment trial, how would participating in something like this fit alongside my current or planned treatment — and would it interfere in any way?
5Given that my diagnosis involves a CNS tumor, is being evaluated at NCI through a study like this something worth pursuing, or are there standard-of-care options or local trials I should consider first?'}
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate patients with tumors of the central nervous system (CNS) who are probable future candidates for NCI Phase I and II protocols