An observational study in Craniopharyngioma, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-03-08.
Sponsored by St. Jude Children's Research Hospital · Observational
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Among 43 studies in Craniopharyngioma with a site in United States — 5 open to participants now, 12 under way, none of them phase 3. Craniopharyngioma · United States.
Among the 43 studies in Craniopharyngioma with a site in United States, this one is one of 2 that started in 2018, is one of 5 observational ones, and was the 34th registered.
76 studies on the registry are indexed under Craniopharyngioma; 19 are open to participants now.
Browse Craniopharyngioma studies →5 of the 43 studies in Craniopharyngioma with a site in United States are open now. Recruiting first, the newest first:
Parabilis Medicines, Inc. · Sites in United States, Australia
Ages 18+
Nationwide Children's Hospital · Sites in United States, Australia, Canada
Ages 1–39
Nationwide Children's Hospital · Sites in United States, Australia, Canada
Ages 1–39
Sabine Mueller, MD, PhD · Sites in United States, Australia
Ages 1–39
University of Colorado, Denver · Sites in United States
Ages 30 days–21 yrs
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 →
Of the 13 Craniopharyngioma studies recruiting now, 5 (38%) set no upper age limit and 7 (54%) stop at 75 or younger; 5 take children under 18; none take healthy volunteers.
This study: 8 Years to 18 Years · all sexes · no healthy volunteers.
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43 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 20 · Phase 3 2
First in 1994; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 41 is below the median of 180 across 21 observational studies indexed under Craniopharyngioma.
Median enrollment 30 across the 35 interventional studies, 76 across the 5 observational. Of the 29 that completed or were terminated, 11 (38%) have results posted.
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4 of 43 have an industry lead sponsor. The 10 most frequent:
St. Jude Children's Research Hospital is the lead sponsor of 440 studies on the registry; 102 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 37 (61%) have results posted.
St. Jude Children's Research Hospital has 5 studies filed under Craniopharyngioma — fewer than ten, so there is no comparison to draw.
5 of the studies in Craniopharyngioma with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04087902Ohio State UniversityLong-Term Longitudinal QoL in Patients Undergoing EEA | 2026-12-31 |
| NCT05465174Sabine Mueller, MD, PhDTovorafenib for Treatment of Craniopharyngioma in Children and Young Adults | 2027-03-01 |
| NCT05919264Parabilis Medicines, Inc.FOG-001 in Locally Advanced or Metastatic Solid Tumors | 2027-04-01 |
| NCT05286788Nationwide Children's HospitalMEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma | 2027-04-10 |
| NCT00840047St. Jude Children's Research HospitalMethionine PET/CT Studies In Patients With Cancer | 2027-07-27 |
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Among the 43 studies in Craniopharyngioma with a site in United States, from their registry updates:
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Pediatric craniopharyngioma patients experience significant endocrine and sleep dysregulation difficulties. Sleep is a crucial part of children's healthy development, and sleep difficulties are associated with severe functional morbidity. Insufficient sleep, excessive daytime sleepiness, and poor sleep quality have all been significantly related to academic, behavioral, and emotional functioning in children and adolescents. Ecological momentary assessments (EMA) will be used to collect observational data.
EMA data will be collected twice daily for one week. For the morning EMA administration, participants will be asked about their sleep. During the evening administration, participants will be asked about their daytime sleepiness, overall well-being, and family functioning. Covariates also administered during the evening administration include medication administration (Y/N) and total screen time. At the end of the EMA data collection period (on day 7 OR 8), participants will be sent a survey asking them to report - anonymously - their overall experience and satisfaction with the EMA data collection method.
After recruitment and informed consent/assent is obtained for the current study, participants will be asked to complete a questionnaire battery online (via REDCap) assessing sleep habits, daytime sleepiness, family routines, family functioning, and overall quality of life in the past six months. The relationship between subjective sleep ratings obtained from the parent craniopharyngioma study at St. Jude (RT2CR) at diagnosis and 3 months later (T1 and T2) and family functioning/routines at the follow-up study (T3) will be assessed. The researchers have permission to use data for all participants who consent to participate in this follow-up EMA study.
Children will be sent electronic surveys two times per day (i.e., morning and evening) for seven days using Ilumivu software (https://ilumivu.com/mema-demo). Ilumivu is an established EMA tool that offers an in-mobile app for participants to respond to questionnaires in real time with limited burden. This application will send notifications to participants to remind them to complete surveys and record response times for each survey.
Participants for the proposed study will be children who participated in the parent study (ages 8-18 at the time of enrollment on RT2CR) and have an ongoing relationship with the study team. They will be contacted during their follow-up clinic visits and invited to participate in this additional study. Parental consent and participant assent (if age \<18) or consent (if age ≥18) for the proposed study will be obtained in-person.
Two institutions will collaborate in the proposed project: St. Jude Children's Research Hospital (SJCRH) and Virginia Commonwealth University (VCU), however, recruitment, patient enrollment, and data collection will only take place at St. Jude.
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Exclusion Criteria:
The ecological momentary assessment (EMA) will be used for participants to complete surveys from home on two occasions each day over seven days.
Rate of participation
Study feasibility will be assessed by calculating the participation rate as follows: the number of participants who agree to participants divided by the number who are approached to participate.
Time frame: Once at enrollment
Ran from Feb 2018 to primary completion in Jan 2019, 11 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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