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NCT02544022 · ClinicalTrials.gov registry record
Development and Validation of Patient Reported Outcome (PRO) Measures for Individuals With Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (pNFs)
A clinical trial of Neurofibromatosis 1 and Plexiform Neurofibromas, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- 476
- Enrollment target
- 6
- Study locations
NCT02544022: Recruiting study of Neurofibromatosis 1 and Plexiform Neurofibromas, sponsored by National Cancer Institute (NCI).
NCT02544022 is a study of Neurofibromatosis 1 and Plexiform Neurofibromas that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 476 participants, below the 1,016-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (53% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02544022, a study of Neurofibromatosis 1 and Plexiform Neurofibromas, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- 476 participants
- Enrollment target
- 6
- Study locations
Study Summary
Background: People with neurofibromatosis 1 (NF1) who have plexiform neurofibromas (pNFs) can have pain that affects their daily lives. This study aims to improve questionnaires that measure their pain, daily living, and physical functioning. Objectives: To examine and improve questionnaires about daily living for people with NF1 and pNFs. Eligibility: People ages 5 and older with NF1 and a pNF Design: Participants will be screened with medical history. This study will have 2 phases. Phase 1 participants will talk about existing pain assessment questionnaires and how pNFs affect their life. They will have group discussions of up to 8 people of a similar age with NF1 and pNFs, or the parents of children with it. These will last about 90 minutes. Children ages 5 to 7 and their parents will have one-on-one meetings instead. These will last about 45 minutes. Discussions will be audiotaped. After the questionnaires have been changed, individual interviews will discuss the new wording, instructions, questions, and electronic format of the new forms. Phase 2 is now complete. Phase 1 participants may be invited to Phase 2. Phase 2 participants will complete the new questionnaires. These may be pen-and-paper or electronic. The questionnaires will take about 30 minutes for adults and teens. Children will work one-on-one with a staff member and may need up to 45 minutes. A small group of participants will be complete the forms twice-in clinic and 1 month later at home. Also, a small group who start a new pain treatment or have a dose increase in their treatment will complete the forms twice-before the treatment change and 1 month later.
Primary Outcome
To evaluate final versions of the NRS-11, PII, and PROMIS-PF measures on reliability, validity, sensitivity to change, and feasibility in individuals with NF1 and PNs.
Conditions Studied
Study Locations (6)
Maryland
- Johns Hopkins University - Baltimore
- National Institutes of Health Clinical Center - Bethesda
District of Columbia
- Children's National Medical Center - Washington D.C.
Illinois
- University of Chicago - Chicago
Ohio
- Cincinnati Children's Hospital and Medical Center Institution - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 476 participants |
| Start Date | 2015-11-13 |
| Est. Completion | 2026-12-31 |
What NCT02544022 shows while recruiting
NCT02544022 is an observational study that tracks outcomes without assigning an intervention. The registered 476 participants enrollment target is mid-sized for trials with a published cap, below the 1,016-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (53% lower).
The record links to 2 conditions, with Neurofibromatosis 1 appearing as the primary indexed condition, and to 0 interventions.
NCT02544022 lists 6 locations in 5 states (Maryland, District of Columbia, Illinois).
Frequently Asked Questions
What is clinical trial NCT02544022 about?
NCT02544022 is a clinical study titled "Development and Validation of Patient Reported Outcome (PRO) Measures for Individuals With Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (pNFs)". Background: People with neurofibromatosis 1 (NF1) who have plexiform neurofibromas (pNFs) can have pain that affects their daily lives. This study aims to improve questionnaires that measure their pain, daily living, and physical functioning. Objectives: To examine and improve questionnaires abou...
What is the current status of trial NCT02544022?
This trial is currently recruiting. The enrollment target is 476 participants. The study started on 2015-11-13. Estimated completion is 2026-12-31.
What conditions does trial NCT02544022 study?
This clinical trial studies the following conditions: Neurofibromatosis 1, Plexiform Neurofibromas.
Who is sponsoring clinical trial NCT02544022?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02544022 being conducted?
This trial has 6 study locations across District of Columbia, Illinois, Maryland, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neurofibromatosis 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02544022's enrollment target sits among peer trials
476 5th of 24 higher than 20 of 24 other Neurofibromatosis 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurofibromatosis 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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