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Rare CNS Tumors Outcomes &Risk

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ClinicalTrials.gov Identifier: NCT03251989
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

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.

(Registered Trademark)

  • 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

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1650 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploring Outcomes and Risk in Patients With Rare Central Nervous System Tumors
Estimated Study Start Date : March 29, 2019
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 26, 2022


Group/Cohort
Participants
participants greater than or equal to 18 years of age who self-identify as being diagnosed with an ependymoma.



Primary Outcome Measures :
  1. 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 ependymomarare 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 ependymomarare CNS tumors participant population. To explore genomic susceptibility in participants with ependymomarare 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
Participants will be solicited through the Collaborative Ependymoma Research Network (CERN), information on the Neuro-Oncology Branch website and other advocacy organization websites, mailing list and social media sites.@@@
Criteria
  • INCLUSION CRITERIA:

Participants with rare CNS tumors who meet the following criteria will be invited to participate in the study:

  • A diagnosis of rare CNS tumors, (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) or as reported by the participant
  • Patients who were more than 18 years of age at the time of initial rare CNS tumor diagnosis will be included in the Adult rare CNS and Risk Survey cohorts.
  • Ability to speak, write, and read English, as questionnaires available in English language only.
  • Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

-Participants who were <18 years at the age at the time of initial rare CNS tumors diagnosis and are currently greater than or equal to 18 years of age will be included in a subsequent study that will include pediatric participants and their families.


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): NCT03251989


Contacts
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Contact: Alvina Acquaye (240) 760-6430 alvina.acquaye@nih.gov

Locations
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United States, Maryland
National Cancer Institute (NCI) Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Terri S Armstrong, C.R.N.P. National Cancer Institute (NCI)

Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03251989     History of Changes
Other Study ID Numbers: 999917141
17-C-N141
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: January 4, 2019

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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
Central Nervous System
Choroid Plexus Tumors
Gliomas
Atypical Teratoid Rhabdoid Tumor

Additional relevant MeSH terms:
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Ependymoma
Meningioma
Medulloblastoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neuroectodermal Tumors, Primitive