Clinical and Demographic Characteristics of Adult p Atients With NEurofibromatosis in RUSsia

Last updated: March 30, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Warts

Neurofibromatosis

Brain Tumor

Treatment

N/A

Clinical Study ID

NCT07088991
D134BR00007
  • All Genders

Study Summary

Clinical and Demographic Characteristics of Adult Patients with NEurofibromatosis in RUSsia (NEREUS)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years at the time of inclusion.

  2. Signed and dated written informed consent in accordance with ICH-GCP and local lawprior 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 radiographicfindings).

  5. Existing of PN-associated symptoms.

  6. Adult patients (≥18 years) with newly diagnosed PN or established PN naïve toMEK-inhibitor therapy verified by medical records/histories (e.g., priorprescriptions, hospitalization data).

Exclusion

Exclusion Criteria:

  1. The participation in any clinical study currently (patients participating in othernon-interventional studies may be included);

  2. Patients with the evidence of a malignant glioma, malignant peripheral nerve sheathtumor, or other cancer, requiring treatment with chemotherapy or radiation therapy.

  3. In the opinion of the investigator the patient is not able to return for follow-upvisits or obtain required follow-up studies.

  4. Individuals who are pregnant or breast feeding or who become pregnant while enrolledon this trial, if they are unable to undergo radiographic evaluations or MRI scansrequested for research purposes, or other studies which might negatively impact onthe pregnancy.

  5. Prior receipt of any MEK-inhibitor for PN therapy within 4 months before screeningor initiation of therapy prior to age 18 verified by medical records/histories (e.g., prior prescriptions, hospitalization data).

  6. Patients who modify their index pathogenetic therapy regimen during the study (forexample, pathogenetic antitumor therapy of PN; switching to a different therapy), asdetermined by the investigator at any protocol-specified visit during the a study,will be excluded from the primary efficacy analysis population from the point ofmodification onward and will not continue study participation.

Study Design

Total Participants: 200
Study Start date:
June 06, 2025
Estimated Completion Date:
March 31, 2028

Study Description

Open-label single-arm, non-interventional, multi-center, cohort study for evaluation of clinical and patient reported outcomes in routine care settings

Connect with a study center

  • Research Site

    Arkhangelsk,
    Russia

    Active - Recruiting

  • Research Site

    Arkhangelsk 581049,
    Russia

    Site Not Available

  • Research Site

    Chelyabinsk,
    Russia

    Active - Recruiting

  • Research Site

    Chelyabinsk 1508291,
    Russia

    Site Not Available

  • Research Site

    Krasnoyarsk,
    Russia

    Active - Recruiting

  • Research Site

    Krasnoyarsk 1502026,
    Russia

    Site Not Available

  • Research Site

    Kurgan,
    Russia

    Active - Recruiting

  • Research Site

    Moscow,
    Russia

    Active - Recruiting

  • Research Site

    Moscow 524901,
    Russia

    Site Not Available

  • Research Site

    Nizhny Novgorod,
    Russia

    Active - Recruiting

  • Research Site

    Nizhny Novgorod 520555,
    Russia

    Site Not Available

  • Research Site

    Novosibirsk,
    Russia

    Active - Recruiting

  • Research Site

    Novosibirsk 1496747,
    Russia

    Site Not Available

  • Research Site

    Orenburg,
    Russia

    Active - Recruiting

  • Research Site

    Saint Petersburg 498817,
    Russia

    Site Not Available

  • Research Site

    Saint-Peretsburg,
    Russia

    Active - Recruiting

  • Research Site

    Samara,
    Russia

    Active - Recruiting

  • Research Site

    Samara 499099,
    Russia

    Site Not Available

  • Research Site

    Tomsk,
    Russia

    Active - Recruiting

  • Research Site

    Tomsk 1489425,
    Russia

    Site Not Available

  • Research Site

    Ufa,
    Russia

    Active - Recruiting

  • Research Site

    Ufa 479561,
    Russia

    Site Not Available

  • Research Site

    Yekaterinburg,
    Russia

    Active - Recruiting

  • Research site

    Yekaterinburg 1486209,
    Russia

    Site Not Available

  • Research site

    Moscow,
    Russian Federation

    Site Not Available

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