RecruitingNot Applicable

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

Russia200 participantsStarted 2025-06-06

Plain-language summary

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

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Age (full years) at the inclusion into the study (date of Visit 1)

Timeframe: Day 0 (Visit 1)

Age (full years) at the primary NF1 diagnosis

Timeframe: Day 0 (Visit 1)

Proportion of men and women

Timeframe: Day 0 (Visit 1)

Body mass index (BMI), kg/m2;

Timeframe: Day 0 (Visit 1)

Body surface area (BSA), m2

Timeframe: Day 0 (Visit 1)

Proportion of patients with each educational status (higher, secondary special, secondary general);

Timeframe: Day 0 (Visit 1)

Proportion of patients from each residential region (federal district of Russia);

Timeframe: Day 0 (Visit 1)

Trial details

NCT IDNCT07088991

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-03-31

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Neurofibromatosis trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Exclusion criteria

. 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.

What they're measuring

Age (full years) at the inclusion into the study (date of Visit 1)

Timeframe: Day 0 (Visit 1)

Age (full years) at the primary NF1 diagnosis

Timeframe: Day 0 (Visit 1)

Proportion of men and women

Timeframe: Day 0 (Visit 1)

Body mass index (BMI), kg/m2;

Timeframe: Day 0 (Visit 1)

Body surface area (BSA), m2

Timeframe: Day 0 (Visit 1)

Proportion of patients with each educational status (higher, secondary special, secondary general);

Timeframe: Day 0 (Visit 1)

Proportion of patients from each residential region (federal district of Russia);

Timeframe: Day 0 (Visit 1)