Medical Marijuana in the Pediatric Central Nervous System Tumor Population

NCT03052738 | Completed DMC

• 1 other identifier: 15-0404.cc
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study proposes to do a prospective observational cohort study evaluating the quality of life (QOL) of children with Central Nervous System (CNS) tumors and their families who choose to self-medicate with marijuana-derived products while undergoing treatment at Children's Hospital Colorado (CHCO).

Conditions

Central Nervous System Tumor; Brain Tumor; Spinal Tumor

Keywords

central nervous system (brain or spinal) tumor

Outcome Measures

Primary Outcomes (1)

• Overall Quality of Life

  quality-of-life scores as assessed by the validated PedsQL™ brain tumor (PedsQL™-BT) module

  1 year

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observational cohort study evaluating the quality of life (QOL) of children with CNS tumors and their families who choose to self-medicate with marijuana-derived products while undergoing treatment at CHCO.

You may qualify if:

• Age \> 2 years and \< 18 years at the time of study enrollment.
• Parents/legal guardian(s) that will be completing the questionnaires must sign consent. There are no age parameters for parent/legal guardians' participation on study.
• Patients must have a diagnosis of central nervous system (brain or spinal) tumor
• Patients must be ONE of the following:
• Undergoing disease-directed therapy or disease surveillance as prescribed by the Pediatric Neuro-Oncology physicians at CHCO
• Planning to transfer medical care to Pediatric Neuro-Oncology physicians at CHCO from outside facilities
• Receiving palliative care services that are managed in conjunction with physicians at CHCO
• Interest in marijuana use has been discussed by the patient or parents.
• Patient has not used any marijuana products or synthetics in the last 14 days (a washout period of 14 days is permitted for those interested in participating on this study)
• An exception to this rule is if patients took their first dose within 72 hours of signing consent. These patients will be eligible for study without going through a washout period.

You may not qualify if:

• Use (or planned use) of synthetic marijuana products as sole cannabinoid therapy

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Chilsdren's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral Blood

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Spinal Cord Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Spinal Cord Diseases

Study Officials

• Nicholas K Foreman, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 14, 2017
• Study Start: January 15, 2016
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)