Protocol Details
The Impact of Ras/MAPK Signaling Pathway-Targeted Therapies on Neurocognitive Functioning in Individuals with NF1
This study is NOT currently recruiting participants.
Summary
Number |
15-C-0019 |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 4
Max Age: 99 |
Referral Letter Required |
Yes |
Population Exclusion(s) |
None |
Keywords |
Working Memory;
Attention;
Processing Speed;
Learning/Memory;
Cognitive Performance;
Natural History |
Recruitment Keyword(s) |
None |
Condition(s) |
Neurofibroma, Plexiform |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Cancer Institute |
Background:
- Neurofibromatosis type 1 (NF1) is a genetic disease. It causes tumors to grow along nerves throughout the body. People with NF1 can have problems with learning and cognitive (thinking) abilities like attention and memory. Researchers want to see if some drugs used to treat tumors in people with NF1 may affect their learning and cognitive skills.
Objective:
- To evaluate learning and cognitive abilities in people with NF1 who have a tumor that is being treated with certain types of drugs.
Eligibility:
- People age 4 to 35 with NF1. They must have a tumor that is going to be treated with a MEK/BRAF pathway inhibitor. This treatment will be in a separate study.
Design:
- Participants will have a brief cognitive test to evaluate attention, memory and other learning skills. They will be asked to respond to different things on a computer screen.
- Participants will answer questions about their everyday behavior and functioning. For those 6 to 17 years of age, their parent or guardian will answer the questions.
- Participants will then go through their drug treatment trial. This will be in a separate study.
- Participants will have repeat cognitive test about 12 weeks after they start taking the drug in the treatment trial. The third testing session will happen at approximately 24 weeks after they started treatment.
- Participants will have a final testing session about 48 weeks after they started treatment. If they stop the study, they will do this testing at the last study visit while they are still on the study drug.
Eligibility
INCLUSION CRITERIA:
- Diagnosed with Neurofibromatosis Type 1 (NF1) per NIH criteria or germline NF1 mutation in a CLIA laboratory
- Children, adolescents and adults (age 4 to 35 years) with NF1
- Being screened for enrollment or enrolled on a clinical trial involving a MEK/BRAF pathway inhibitor targeting glioma or plexiform neurofibroma (PN)
- Aged 4 to 35 years at time of study consent
- Must be English, French or Spanish-speaking (languages in which the assessment tools are available)
- No significant sensory or motor impairment that would interfere with the participant s ability to participate in the assessment (e.g., blindness, deafness, significant motor impairment)
Citations:
Not Provided
Contacts: