Clinical and Demographic Characteristics of Adult p Atients With NEurofibromatosis in RUSsia
ConditionNeurofibromatosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAstraZeneca
About this trial
Clinical and Demographic Characteristics of Adult Patients with NEurofibromatosis in RUSsia (NEREUS)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years at the time of inclusion.
Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the study.
NF1 diagnosed (according to the international consensus criteria for evaluating NF1 [18]), see Appendix A.
Confirmed PN by clinical assessment, USI, MRI, biopsy; one method is sufficient (histologic confirmation of PN is not necessary in the presence of radiographic findings).
Disqualifiers
The participation in any clinical study currently (patients participating in other non-interventional studies may be included);
Patients with the evidence of a malignant glioma, malignant peripheral nerve sheath tumor, or other cancer, requiring treatment with chemotherapy or radiation therapy.
In the opinion of the investigator the patient is not able to return for follow-up visits or obtain required follow-up studies.
Individuals who are pregnant or breast feeding or who become pregnant while enrolled on this trial, if they are unable to undergo radiographic evaluations or MRI scans requested for research purposes, or other studies which might negatively impact on the pregnancy.
Trial population
1. Age ≥ 18 years at the time of inclusion. 2. Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the study. 3. NF1 diagnosed (according to the international consensus criteria for evaluating NF1 \[18\]), see Appendix A. 4. Confirmed PN by clinical assessment, USI, MRI, biopsy; one method is sufficient (histologic confirmation of PN is not necessary in the presence of radiographic findings). 5. Existing of PN-associated symptoms. 6. Adult patients (≥18 years) with newly diagnosed PN or established PN naïve to MEK-inhibitor therapy verified by medical records/histories (e.g., prior prescriptions, hospitalization data).
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Age (full years) at the inclusion into the study (date of Visit 1)
To achieve the primary objectives of the study the following baseline clinical and demographic characteristics of patients will be collected or evaluated. The term 'baseline' means that the data is obtained at the inclusion into the study (Visit 1) during retrospective data collection from patient medical documentation or via interview with a patient on Visit 1, where applicable.
Time frame
Day 0 (Visit 1)2
Age (full years) at the primary NF1 diagnosis
To achieve the primary objectives of the study the following baseline clinical and demographic characteristics of patients will be collected or evaluated. The term 'baseline' means that the data is obtained at the inclusion into the study (Visit 1) during retrospective data collection from patient medical documentation or via interview with a patient on Visit 1, where applicable.
Time frame
Day 0 (Visit 1)3
Proportion of men and women
To achieve the primary objectives of the study the following baseline clinical and demographic characteristics of patients will be collected or evaluated. The term 'baseline' means that the data is obtained at the inclusion into the study (Visit 1) during retrospective data collection from patient medical documentation or via interview with a patient on Visit 1, where applicable.
Time frame
Day 0 (Visit 1)4
Body mass index (BMI), kg/m2;
To achieve the primary objectives of the study the following baseline clinical and demographic characteristics of patients will be collected or evaluated. The term 'baseline' means that the data is obtained at the inclusion into the study (Visit 1) during retrospective data collection from patient medical documentation or via interview with a patient on Visit 1, where applicable.
Time frame
Day 0 (Visit 1)Sponsors and contacts
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Source ClinicalTrials.gov