Status:
COMPLETED
Systematically Assessing Changes in Plexiform Neurofibroma Related Disfigurement From Photographs of Subjects With Neurofibromatosis Type 1 on a Phase 2 Clinical Trial
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Neurofibromatosis 1
Eligibility:
All Genders
7+ years
Brief Summary
Background: People with Neurofibromatosis type 1 (NF1) have an increased risk of developing plexiform neurofibromas (PNs). PNs are tumors that form in the tissue. They can form anywhere in the body. ...
Detailed Description
Background: Up to 50% of subjects with Neurofibromatosis Type 1 (NF1) will develop histologically benign plexiform neurofibromas (PN). One of the most common morbidities associated with PN is a disf...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Clinician Raters - those who are professionally involved with direct patient care and have a career in the medical field and familiar with NF1 (Cohort 1A), OR
- Clinician Raters - those who are professionally involved with direct patient care and have a career in the medical field but are not familiar with NF1 (Cohort 1B), OR
- Non-clinician Raters - those who are not professionally involved in direct patient care or do not have a career in the medical field, but who are a first or second degree relative of a subject with NF1 or are otherwise closely associated with a subject with NF1 and familiar with NF1 (Cohort 2A), OR
- Non-clinician Raters - those who are not professionally involved in direct patient care or do not have a career in the medical field, and who are not a first or second degree relative of a subject with NF1 and are otherwise not closely associated with a subject with NF1 (Cohort 2B)
- Age greater than or equal to18 years.
- The ability of a subject to understand and the willingness to sign a written informed consent document.
- Ability to read and write in English.
- EXCLUSION CRITERIA:
- Raters should not be employees of the NIH.
- Raters should not be directly involved in the NCI Phase 1/2 study of selumetinib (11-C-0161), either as an investigator or as a subject or first-degree family member of a subject enrolled on the trial.
Exclusion
Key Trial Info
Start Date :
May 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 15 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04879160
Start Date
May 12 2021
End Date
August 15 2022
Last Update
March 22 2024
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892