NeurofibromatosisNEREUSNCT07088991
Clinical and Demographic Characteristics of Adult p Atients With NEurofibromatosis in RUSsia
An observational study of Neurofibromatosis, run by AstraZeneca at 16 sites in Russia.
Trial summary
Clinical and Demographic Characteristics of Adult Patients with NEurofibromatosis in RUSsia (NEREUS) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurofibromatosis
- How many people
- 200 participants
- Where
- 16 sitesRussia
- Study dates
- 6 Jun 2025to 31 Mar 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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).
Who may be able to join
- 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).
- Existing of PN-associated symptoms.
- 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).
Who cannot join
- 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.
- Prior receipt of any MEK-inhibitor for PN therapy within 4 months before screening or initiation of therapy prior to age 18 verified by medical records/histories (e.g., prior prescriptions, hospitalization data).
- Patients who modify their index pathogenetic therapy regimen during the study (for example, pathogenetic antitumor therapy of PN; switching to a different therapy), as determined by the investigator at any protocol-specified visit during the a study, will be excluded from the primary efficacy analysis population from the point of modification onward and will not continue study participation.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
16 sites in 1 country
Russia16 sites, 16 recruiting
- Recruiting
Research Site
Arkhangelsk
- Recruiting
Research Site
Chelyabinsk
- Recruiting
Research Site
Grozny
- Recruiting
Research Site
Krasnoyarsk
- Recruiting
Research Site
Kurgan
- Recruiting
Research Site
Moscow
- Recruiting
Research Site
Nizhny Novgorod
- Recruiting
Research Site
Novosibirsk
- Recruiting
Research Site
Orenburg
- Recruiting
Research Site
Perm
- Recruiting
Research Site
Rostov-on-Don
- Recruiting
Research Site
Saint Petersburg
- Recruiting
Research Site
Samara
- Recruiting
Research Site
Tomsk
- Recruiting
Research Site
Ufa
- Recruiting
Research Site
Yekaterinburg
About this study
Official title: Clinical and Demographic Characteristics of Adult Patients With NEurofibromatosis in RUSsia
Clinical and Demographic Characteristics of Adult Patients with NEurofibromatosis in RUSsia (NEREUS)
Read the detailed description
Open-label single-arm, non-interventional, multi-center, cohort study for evaluation of clinical and patient reported outcomes in routine care settings
- Conditions
- Neurofibromatosis
- Medical subject headings
- Neurofibromatoses
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (Visit 1)
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.
Measured: Day 0 (Visit 1)
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.
Measured: Day 0 (Visit 1)
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.
Measured: Day 0 (Visit 1)
Body surface area (BSA), 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.
Measured: Day 0 (Visit 1)
Proportion of patients with each educational status (higher, secondary special, secondary general);
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.
Measured: Day 0 (Visit 1)
Proportion of patients from each residential region (federal district of Russia);
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.
Measured: Day 0 (Visit 1)
Other than PN specific NF1 symptoms and manifestations
skin symptoms and manifestations, tumor manifestations (except malignancies), neurological and cognitive manifestations, cardiovascular manifestations, endocrine manifestations, orthopedic manifestations (distinctive osseous lesions), ophthalmological manifestations, NF1 mutation, presence of NF1 diagnostic criteria in one of parents) (frequency distribution at baseline)
Measured: Day 0 (Visit 1)
NF1-associated complications
malignancy, hypertension, vasculopathy, bone symptoms, chronic neurological conditions, neuropathy, and pain
Measured: Day 0 (Visit 1)
Non-specific NF1-comorbidities, coded by MedDRA system organ class (SOC) and preferred term (PT)
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.
Measured: Day 0 (Visit 1)
Proportion of patients with various specific and non-specific NF1-comorbidities
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.
Measured: Day 0 (Visit 1)
Proportion of patients with various PN-associated symptoms
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.
Measured: Day 0 (Visit 1)
Proportion of patients with various ECOG score
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.
Measured: Day 0 (Visit 1)
Proportion of patients with various PN locations
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.
Measured: Day 0 (Visit 1)
PN volume (established by MRI)
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.
Measured: Day 0 (Visit 1)
Duration of PN symptoms persistence before inclusion into the study
to be calculated between the date when initially symptoms of PN appeared and the date of Visit 1
Measured: Day 0 (Visit 1)
Duration of PN diagnosis before inclusion into the study
to be calculated between the date of primary diagnosis of PN and the date of Visit 1
Measured: Day 0 (Visit 1)
Medical history of PN
size, symptoms, previous medical interventions, surgeries or treatments
Measured: Day 0 (Visit 1)
Previous physical, instrumental and laboratory examination results
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.
Measured: Day 0 (Visit 1)
Amount and duration of hospitalizations associated with NF1 according to the investigator's opinion, collected from the medical history since the date of NF1 diagnosis
if applicable, to be calculated in patients with at least one such hospitalization
Measured: Day 0 (Visit 1)
Degree of disability at baseline
if applicable, to be calculated in patients with presence of disability at Visit 1
Measured: Day 0 (Visit 1)
Changing in disability degree during the study
if applicable, to be calculated in patients with presence of disability at Visit 1
Measured: Day 0 (Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start6 Jun 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurofibromatosisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088991
- Sponsor's protocol ID
- D134BR00007
- Acronym
- NEREUS
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.