We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 5 for:    ALVINA

Outcomes and Risk in People With Ependymoma

This study is currently recruiting participants.
Verified August 3, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT03251989
First Posted: August 16, 2017
Last Update Posted: December 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  Purpose

Background:

Ependymoma is a rare type of primary brain or spine tumor. That means that it starts in the brain or spine. These tumors affect both children and adults. 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 an ependymoma, to eventually screen for these changes or target the genes in treatment.

Eligibility:

People 18 years and older who have an ependymoma tumor

Design:

Participants will be recruited from a research website and a previous study.

Participants will take an online study. It is called the Adult Ependymoma Outcomes Survey. It should take about 15 20 minutes. Participants will be asked for demographic data and about their disease history.

Participants will take another online study. It is called the Adult Ependymoma Risk Survey. It should take about 50 minutes. Participants will be asked about:

Demographic data

Personal medical history

Family medical history

Environmental exposures

Participants who have physical problems can have help with the surveys and forms.

Participants will get a kit in the mail with the materials needed to collect saliva. Participants will ship the sample to the study team in a prepaid envelope.

If the sample is not usable, participants may be asked to give another one.


Condition
Ependymoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploring Outcomes and Risk in Patients With Ependymoma

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):

Primary Outcome Measures:
  • self-reported data on treatment, symptoms, functional status, andquality of life for adult patients with ependymoma [ Time Frame: completion of study ]

Secondary Outcome Measures:
  • To evaluate the relationship between health status and diseaseand treatment characteristics [ Time Frame: completion of study ]
  • To evaluate self-reported clinical and demographic risk factors inadult patients in the ependymoma patient population. [ Time Frame: completion of study ]
  • To explore genomic susceptibility in patients with ependymoma. [ Time Frame: completion of study ]

Estimated Enrollment: 220
Anticipated Study Start Date: December 19, 2017
Estimated Study Completion Date: February 1, 2019
Estimated Primary Completion Date: February 1, 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants
participants greater than or equal to 18 years of age who self-identify as being diagnosed with an ependymoma.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
participants greater than or equal to 18 years of age who self-identify as being diagnosed with an ependymoma.
Criteria
  • INCLUSION CRITERIA:

Participants with ependymomas who meet the following criteria will be invited to participate in the study:

  • A diagnosis of ependymoma, or ependymoma variant, as reported by the participant
  • Age greater than or equal to 18 at the time of initial ependymoma diagnosis
  • 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 ependymoma 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.

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

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

Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03251989     History of Changes
Other Study ID Numbers: 999917141
17-C-N141
First Submitted: August 15, 2017
First Posted: August 16, 2017
Last Update Posted: December 14, 2017
Last Verified: August 3, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Brain Tumor
Central Nervous System
CNS

Additional relevant MeSH terms:
Ependymoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue