NCT07088991 Clinical and Demographic Characteristics of Adult p Atients With NEurofibromatosis in RUSsia
| NCT ID | NCT07088991 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Neurofibromatosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-06-06 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-06-06 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Clinical and Demographic Characteristics of Adult Patients with NEurofibromatosis in RUSsia (NEREUS)
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07088991 clinical trial?
This trial is open to participants of all sexes, studying Neurofibromatosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07088991 currently recruiting?
Yes, NCT07088991 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07088991 trial being conducted?
This trial is being conducted at Arkhangelsk, Russia, Chelyabinsk, Russia, Grozny, Russia, Krasnoyarsk, Russia and 11 additional locations.
Who is sponsoring the NCT07088991 clinical trial?
NCT07088991 is sponsored by AstraZeneca. The trial plans to enroll 200 participants.