ClinicalTrials.gg
CompletedNCT03052738Updated Aug 29, 2024

Medical Marijuana in the Pediatric Central Nervous System Tumor Population

An observational study in Central Nervous System Tumor, Brain Tumor and Spinal Tumor, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-08-29.

Primary conditionBrain NeoplasmsRegistry: Central Nervous System NeoplasmsReclassifiedWhy we changed it
Registry
Central Nervous System Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Brain Neoplasms
Why
  1. The study's listed conditions name Brain Neoplasms, a narrower term within Central Nervous System Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
19
Ages
2 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,443 studies in Brain Neoplasms with a site in United States — 229 open to participants now, 352 under way, 18 of them phase 3. Brain Neoplasms · United States.

Enrollment
152nd of 191
19 · median 76
Started
2016
with 63 others
Observational
193 of 1,443
36 open now
Registered
942nd of 1,443
by date

Among the 1,443 studies in Brain Neoplasms with a site in United States, this one is the 152nd largest by enrollment of the 191 observational ones that give a count, is one of 64 that started in 2016, is one of 193 observational ones, and was the 942nd registered.

Brain Neoplasms

2,441 studies on the registry are indexed under Brain Neoplasms; 541 are open to participants now.

Browse Brain Neoplasms studies →

Open to participants now

229 of the 1,443 studies in Brain Neoplasms with a site in United States are open now. Recruiting first, the newest first:

224 more — sign in →

All 229 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 424 Brain Neoplasms studies recruiting now, 285 (67%) set no upper age limit and 82 (19%) stop at 75 or younger; 80 take children under 18; 36 take healthy volunteers.

This study: 2 Years to 18 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,443 studies in Brain Neoplasms with a site in United States, or all of them as a file.
02

Study 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).

Read the detailed description

Children's Hospital Colorado (CHCO) Center for Cancer and Blood Disorders (CCBD) is a national leader in pediatric cancer therapy. The CHCO Neuro-Oncology program treats more that 90% of Coloradan children with Central Nervous System (CNS) tumors and a large percentage of children with CNS tumors from the surrounding five states. Due to advances in therapy, approximately two-thirds of children with CNS tumors treated at CHCO will be cured. Although medical marijuana has been legal for more than a decade in Colorado, the publicity around the more recent legalization for general adult use, increasing literature, and anecdotal reports of patients with terminal CNS tumors cured with medical marijuana, have prompted a recent increase in interest of current CHCO patients and their families. There has been an influx of pediatric cancer patients and their families moving to Colorado to obtain these marijuana-based products to self-medicate.

The Investigators will administer PedsQLTM questionnaires and diaries to gather data regarding use practices, method of delivery, strain used, dosing and frequency, and family financial impact on all enrolled patients. The Investigators will also collect peripheral blood samples to evaluate for evidence of immuno-modulation by cannabinoids in patients who may already be immunocompromised and to assess blood cannabinoid levels.

This study will provide novel exploratory data regarding use patterns, impact on families and resources, and potential clinical benefits and harms associated with the growing marijuana use in the pediatric neuro-oncology population. Such information may guide future children afflicted with CNS tumors and their families to make decisions about whether to pursue cannabinoid treatment.

03

Conditions studied

  • Central Nervous System Tumor
  • Brain Tumor
  • Spinal Tumor

Keywords

  • central nervous system (brain or spinal) tumor
04

In context

Brain Neoplasms Reclassified

2,441 studies on the registry are indexed under Brain Neoplasms; 541 are open to participants now.

This study's enrollment of 19 is below the median of 99 across 433 observational studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.

Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Compared within Brain Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Central Nervous System Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age > 2 years and \< 18 years at the time of study enrollment.
  2. 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.
  3. Patients must have a diagnosis of central nervous system (brain or spinal) tumor
  4. 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
  5. Interest in marijuana use has been discussed by the patient or parents.
  6. Patient has not used any marijuana products or synthetics in the last 14 days (a of 14 days is permitted for those interested in participating on this study)

    1. 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.

Exclusion criteria

Exclusion Criteria:

  1. Does not meet inclusion criteria
  2. Use (or planned use) of synthetic marijuana products as sole cannabinoid therapy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
19 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
07

What researchers measure

Primary outcomes

  1. Overall Quality of Life

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

    Time frame: 1 year

08

Study locations

1 site
  • Chilsdren's Hospital Colorado
    Aurora, Colorado 80045, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2016 to primary completion in Jun 2020, 53 months.

Of 181 non-industry observational studies under Brain Neoplasms, half reached primary completion within 82 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 269. This study's 53 months is below that.

Counting every sponsor, half of 199 studies reached it within 82 months; a quarter within 41 and three quarters within 269.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2017
First posted
Feb 14, 2017
StartActual
Jan 15, 2016
Primary completionActual
Jun 30, 2020
CompletionActual
Jun 30, 2020
Last update
Aug 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03052738
Responsible party
Sponsor
First posted
Feb 14, 2017
Start date
Jan 15, 2016
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Last update
Aug 29, 2024

Study contacts

Nicholas K Foreman, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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