MedDataX Logo

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

NCT ID: NCT07088991

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-06

Study Completion Date

2028-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurofibromatosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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).

Exclusion Criteria

1. The participation in any clinical study currently (patients participating in other non-interventional studies may be included);
2. Patients with the evidence of a malignant glioma, malignant peripheral nerve sheath tumor, 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-up visits or obtain required follow-up studies.
4. 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.
5. 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).
6. 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Arkhangelsk, , Russia

Site Status RECRUITING

Research Site

Chelyabinsk, , Russia

Site Status RECRUITING

Research Site

Krasnoyarsk, , Russia

Site Status RECRUITING

Research Site

Moscow, , Russia

Site Status RECRUITING

Research Site

Nizhny Novgorod, , Russia

Site Status RECRUITING

Research Site

Novosibirsk, , Russia

Site Status RECRUITING

Research Site

Saint-Peretsburg, , Russia

Site Status RECRUITING

Research Site

Samara, , Russia

Site Status RECRUITING

Research Site

Ufa, , Russia

Site Status RECRUITING

Research Site

Yekaterinburg, , Russia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Russia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

AstraZeneca Clinical Study Information Center

Role: CONTACT

[email protected]
1-877-240-9479

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D134BR00007

Identifier Type: -

Identifier Source: org_study_id