Rare CNS Tumors Outcomes &Risk
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|ClinicalTrials.gov Identifier: NCT03251989|
Recruitment Status : Suspended (Strategic planning for the types of tumors is being done. Temp hold until AM is submitted.)
First Posted : August 16, 2017
Last Update Posted : January 3, 2023
Primary tumors of the brain and spine are those that start in the brain or spine. These tumors are rare, accounting for <2% of all cancers diagnosed in the United States. Some of these tumors occur in less than 2,000 people per year. Researchers want to study a large group of people with this kind of tumor. They want to learn more about the tumors, including the risk factors related to how they develop in adults.
Objective: To collect health and gene data to learn about what changes are associated with a rare CNS Tumors, to eventually screen for these changes or target the genes in treatment.
Eligibility: Adult participants (Bullet) 18 years of age who self- identify as being diagnosed with one of 12 rare CNS tumors, including: Atypical teratoid rhabdoid tumor (ATRT); Brainstem and midline gliomas; Choroid plexus tumors; Ependymoma; High grade meningioma; Gliomatosis cerebri; Medulloblastoma; Oligodendroglioma / Anaplastic oligodendroglioma; Pineal region tumors; Pleomorphic xanthroastrocytoma / Anaplastic pleomorphic xanthroastrocytoma; PNET (Supratentorial embryonal tumor); Primary CNS sarcoma / Secondary CNS sarcoma (Gliosarcoma).
Design: (Registered Trademark)Participants will be invited to participate through an ad on the CERN Foundation website (ependymoma), information on the Neuro-Oncology Branch website and other identified advocacy and social media sites and direct mailer to those who have already participated in the EO projects. (Registered Trademark)
- Interested participants will complete an enrollment form that will be sent to the study coordinator.
- The coordinator will then send the participant a consent form and schedule a time for phone consent.
- Participants will complete the Rare CNS tumors Outcomes Survey and once completed, the Rare CNS tumors Risk survey.
- The questions on the Outcomes Survey will include treatment history, symptoms social and clinical information and it should take about 25-35 minutes. The Risk survey will cover their demographic information, personal medical history, family medical history and environmental exposures. This should take about 52 minutes.
- Participants who have physical problems can have help with the surveys and forms.
- Once the surveys are completed, participants will be mailed a kit to collect saliva for germline DNA. Participants will ship the sample to the study team in a prepaid envelope
- If the sample is not sufficient, participants will be contacted to give provide an additional sample.
|Condition or disease|
|High Grade Meningioma Ependymoma Medulloblastoma PNET Primary CNS Sarcoma|
|Study Type :||Observational|
|Actual Enrollment :||326 participants|
|Official Title:||Exploring Outcomes and Risk in Patients With Rare Central Nervous System Tumors|
|Actual Study Start Date :||August 21, 2017|
|Estimated Primary Completion Date :||February 1, 2025|
|Estimated Study Completion Date :||February 26, 2025|
1/Patient with a rare CNS diagnosis
A diagnosis of rare CNS Tumors
- Relationship between health status and disease and treatment characteristics as well as clinical and demographic risk factors as self reported by adult participants with rare CNS tumors; and the relationship of genomic susceptibility of the popu... [ Time Frame: completion of study ]Obtain self-reported data on treatment, symptoms, functional status, and quality of life for adult participants with rare CNS tumors To evaluate the relationship between health status and disease and treatment characteristics. To evaluate self-reported clinical and demographic risk factors in adult participants in the rare CNS tumors participant population. To explore genomic susceptibility in participants with rare CNS tumors.
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): NCT03251989
|United States, Maryland|
|National Cancer Institute (NCI)/ Neuro-Oncology Branch|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Terri S Armstrong, C.R.N.P.||National Cancer Institute (NCI)|