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Trial Title:
Non-interventional Study of Patients With PN NF1 Starting Selumetinib in Russia
NCT ID:
NCT05891847
Condition:
Neurofibroma
Conditions: Official terms:
Neurofibroma
Neurofibromatoses
Conditions: Keywords:
NON-INTERVENTIONAL
Selumetinib
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
Summary:
The purpose of this study is to evaluate the effectiveness, safety of selumetinib and
patient's parameters of symptomatic inoperable PN NF1 in real clinical practice in Russia
Detailed description:
This study will be non-interventional retrospective and prospective study. Assessment of
parameters will be carried out as if a patient is treated in real-life clinical setting.
The patients should be enrolled into this project after evaluation of eligibility
criteria by an investigator 10 clinical sites. No additional procedures besides those
already used in the routine clinical practice will be applied to the patients. Study
population will consist of pediatric patients aged 3 years and older with NF1 and
symptomatic inoperable PN who were prescribed with selumetinib
Criteria for eligibility:
Study pop:
Study population will consist of pediatric patients aged 3 years and older with NF1 and
symptomatic inoperable PN who were prescribed with selumetinib
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- NF1 diagnosed (according to the criteria for evaluating NF1),
- Symptomatic inoperable PN,
- Patients receiving therapy with selumetinib. For newly treated patients -
registration on the first day of starting treatment with selumetinib,
- Age at starting of selumetinib treatment ≥ 3 to ≤ 18 years old (included in the
study or started the therapy at the age of 18 years old),
- Patients whose parents or guardians have signed a consent form.
Exclusion Criteria:
- Patients currently participating in an interventional study/clinical trial,
- Patients are excluded if there is evidence of an optic glioma, malignant glioma,
malignant peripheral nerve sheath tumor, or other cancer, requiring treatment with
chemotherapy or radiation therapy,
- Patients who receive other antitumor treatment options on optic nerve glioma,
malignant glioma, malignant tumor of the peripheral nerve sheath, or other cancer.
If the patient on selumetinib treatment develop optic nerve glioma, malignant
glioma, malignant tumor of the peripheral nerve sheath, or other cancer, he can
continue selumetinib therapy +\- other treatment options on physician decision,
- Female patients above 12 age who are pregnant /plan to become pregnant or at breast
feeding.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Moscow
Zip:
123112
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Ekaterinburg
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Moscow
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Novosibirsk
Country:
Russian Federation
Facility:
Name:
Research Site
Address:
City:
Saint-Petersburg
Country:
Russian Federation
Start date:
March 21, 2023
Completion date:
March 20, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05891847
