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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02851706
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Cancer Institute (NCI)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michelle L Wright, Ph.D.
Principal Investigator Affiliation	National Cancer Institute (NCI)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Cancer, Brain Tumor, Spine Cancer, Spine Tumor, Neoplasm
Study Website:	View Trial Website

Additional Details

Background: This protocol is designed to meet an unmet need in neuro-oncology by evaluating patients with CNS tumors throughout their disease course. Data may be collected from multiple sources including medical records tests, and objective and subjective measures in patients and their caregivers. 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.

- Caregivers, as identified by the patient are important to assess internal and external resources (e.g., coping mechanisms), identify specific factors that help patients with primary brain tumors face the uncertainty in their daily lives.

- Ability of patient 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 participants will be accrued to this study.

- Caregivers will be defined as anyone who patients identify as an unpaid close friend or family member who knows the NHS participant well and who is involved with their day-to-day care.

- 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.

Arms & Interventions

Arms

: First cohort Patients (Person with the disease)

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.

: Second cohort Caregivers (Informants)

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.

Interventions

Other: - No Treatment

Survey or Questionnaire Completion with or without Sample Submission

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892