Rare CNS Tumors Outcomes &Risk

  • STATUS
    Recruiting
  • End date
    Feb 26, 2022
  • participants needed
    1650
  • sponsor
    National Cancer Institute (NCI)
Updated on 25 January 2021
cancer
meningioma
ependymoma
gliosarcoma
oligodendroglioma
anaplastic oligodendroglioma
sarcoma
oligodendroglioma, anaplastic
medulloblastoma
atypical teratoid/rhabdoid tumor
pnet
central nervous system tumor
primitive neuroectodermal tumor
rhabdoid tumor

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.

Description

Background

Rare cancers are defined as those with <40,000 cases per year. There are over 130 separate types of primary CNS tumors, all of which meet the definition of a rare cancer. However, some CNS cancers have incidences of less than 1,000 cases per year. Because of its relative rarity, limited reports of the presentation and clinical course have been completed. With the support of the CERN-Foundation, the Adult Ependymoma Outcomes Projects (AEO) was launched to address this lack of information for one type of rare CNS tumor- ependymoma. Using an online platform, participants and families from across the world have participated, providing information that has helped elucidate the presentation and ongoing health of individuals with this disease. To date, over 300 adults have participated with over 95% reporting interest in continuing and expanding their participation. Results from the AEO baseline survey and a follow-up survey (AEOII addressing socioeconomic impact of the disease) have been published. The most recent data from the AEO has been presented at the Society for Neuro-Oncology (SNO) annual meetings in 2015 and 2016.

An additional consequence of the relative rarity of these CNS tumors, studies to evaluate risk factors for the occurrence of these rare CNS tumors or predicting the clinical course of these rare CNS tumors are also limited. Rare CNS tumors like other cancers, occur when there are changes to genes that control the way cells grow and divide often as a result of exposure to other environmental risk factors. Therefore, exploring genetic changes in persons with rare CNS tumors will allow us to begin to understand what changes are associated specifically with these tumors. To date, these participants are often included as part of larger cohorts which include other types of brain tumors. We now understand that even among gliomas, the risk factors differ. Therefore, identifying the risk factors specifically associated with rare CNS tumors is critical for primary prevention and early detection. This knowledge would allow scientists and physicians to eventually screen for these changes or target the genes or the processes they control for treatment purposes.

Objectives

The primary objectives of this study are to:

  • 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 tumor participant population.
  • To explore genomic susceptibility in participants with rare CNS tumors.
    Eligibility

The adult rare CNS tumor population for this study are participant greater than or equal to 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
  • Choroid plexus carcinoma
  • Choroid plexus papilloma
  • Atypical choroid plexus papilloma
  • Ependymoma

-- Subependymoma

-- Myxopapillary ependymoma

  • Papillary ependymoma
  • Clear cell ependymoma
  • Tanycytic ependymoma
  • RELA fusion-positive
  • Anaplastic ependymoma
  • Posterior Fossa A
  • Posterior Fossa B
  • High grade meningioma

-- Chordoid meningioma

-- Clear cell meningioma

-- Atypical meningioma

-- Papillary meningioma

-- Rhabdoid meningioma

-- Anaplastic (malignant) meningioma

  • Gliomatosis cerebri
  • Medulloblastoma
  • Sonic Hedge Hog (SHH)
  • WNT
  • Group 3
  • Group 4
  • Oligodendroglioma / Anaplastic oligodendroglioma
  • Pineal region Tumors
  • Pineoblastoma
  • Pineocytoma
  • Pineal parenchymal tumor of intermediate differentiation
  • Papillary tumor of the pineal region
  • Pleomorphic xanthroastrocytoma / Anaplastic pleomorphic xanthroastrocytoma
  • PNET (Supratentorial embryonal tumor)
  • Primary CNS sarcoma / Secondary CNS sarcoma (Gliosarcoma)
    Design
  • This study represents an ongoing effort to systematically evaluate outcomes in a large

group of participants with these rare tumors. It will provide descriptive data which can

be used to design further studies evaluating interventions related to identified health and

quality of life related issues for this participant population.

  • 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.

  • The goal of adding the Rare CNS tumors Risk Survey is to implement a survey to further

evaluate participants in the EO for several known and suspected risk factors for rare CNS

tumors and to obtain germline DNA to interrogate genomic susceptibility to the disease.

  • Interested participants will complete an enrollment form that will be sent to the study

coordinator. Once submitted, the study coordinator will then send the participant a

consent form and schedule a time for phone consent.

  • Once consent is obtained, the study coordinator will send the subject instructions and a

unique identifier that they will use to access and complete the survey(s).

  • Once the survey is completed, subject will be mailed a kit to collect saliva for germline

DNA.

Details
Condition Ependymoma, Medulloblastoma, Neuroectodermal Tumor, Glioma, Peripheral neuroectodermal tumor, Primitive neuroectodermal tumor, Neurectoderma, High Grade Meningioma, Primary CNS Sarcoma, Gliomas, primitive neuroectodermal tumour, pnet, peripheral neuroepithelioma, peripheral primitive neuroectodermal tumor
Clinical Study IdentifierNCT03251989
SponsorNational Cancer Institute (NCI)
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Gliomas or Glioma or Primitive neuroectodermal tumor or Primary CNS Sarcoma or Neurectoderma or Ependymoma or Peripheral neuroectodermal tumor or High...?
Do you have any of these conditions: Neurectoderma or peripheral primitive neuroectodermal tumor or primitive neuroectodermal tumour or peripheral neuroepithelioma or Ependymoma or Glioma...?
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note