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Clinical and Demographic Characteristics of Adult Patients with NEurofibromatosis in RUSsia (NEREUS)
Open-label single-arm, non-interventional, multi-center, cohort study for evaluation of clinical and patient reported outcomes in routine care settings
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Day 0 (Visit 1) |
| Body surface area (BSA), m2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Arkhangelsk | Russia | |||
| Research Site |
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.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D017253 | Neurofibromatoses |
| ID | Term |
|---|---|
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
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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. |
| 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. | 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. | 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) | Day 0 (Visit 1) |
| NF1-associated complications | malignancy, hypertension, vasculopathy, bone symptoms, chronic neurological conditions, neuropathy, and pain | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | Day 0 (Visit 1) |
| Medical history of PN | size, symptoms, previous medical interventions, surgeries or treatments | 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. | 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 | Day 0 (Visit 1) |
| Degree of disability at baseline | if applicable, to be calculated in patients with presence of disability at Visit 1 | 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 | Day 0 (Visit 1) |
| Recruiting |
| Chelyabinsk |
| Russia |
| Research Site | Recruiting | Krasnoyarsk | Russia |
| Research Site | Recruiting | Kurgan | Russia |
| Research Site | Recruiting | Moscow | Russia |
| Research Site | Recruiting | Nizhny Novgorod | Russia |
| Research Site | Recruiting | Novosibirsk | Russia |
| Research Site | Recruiting | Orenburg | Russia |
| Research Site | Recruiting | Perm | Russia |
| Research Site | Recruiting | Saint Petersburg | Russia |
| Research Site | Recruiting | Samara | Russia |
| Research Site | Recruiting | Tomsk | Russia |
| Research Site | Recruiting | Ufa | Russia |
| Research Site | Recruiting | Yekaterinburg | Russia |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |