SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)

Study Overview
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Brief Summary
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The registry of this study was subjected to patients who were radiologically diagnosed with a non-malignant brain tumor at Seoul National University Hospital since 2001, and who have had magnetic resonance (MR) re-examination after first MR exam or will be re-examined because it was determined that immediate treatment would not be needed at the first visit to the hospital. In all MRs taken by patients, the date of imaging and the volume of the tumor are measured, and we aim to establish a natural growth history for non-malignant brain tumors.

Detailed Description
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Non-malignant central nervous system (CNS) tumor accounts for 70% of all primary CNS tumors, and over 300,000 patients were diagnosed with non-malignant CNS tumor per year in the United States. Not much is known about the natural history of non-malignant CNS tumors, as it is often treated immediately upon detection. However, some of them, especially small and asymptomatic non-malignant CNS tumors should not be treated immediately upon diagnosis but are observed and followed-up by repeated magnetic resonance imaging (MRI). This study aims to make a prospective cohort of non-malignant CNS tumors that do not require immediate treatment and to quantitatively analyze which factors are related to the growth of tumors. The registry of this study was subjected to patients who were radiologically diagnosed with a non-malignant brain tumor at Seoul National University Hospital since 2001, and who have had MR re-examination after first MR exam or will be re-examined because it was determined that immediate treatment would not be needed at the first visit to the hospital. Non-malignant brain tumors are defined as radiologically diagnosed neoplasms of CNS WHO grade 2 or lower among primary intracranial tumors and include meningioma, schwannoma, pituitary adenoma, and glioma suspected to be non-malignant.

Official Title
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The Risk of Growth in Patients With Non-malignant Brain Tumor: SeOuL cOhort of Brain Tumor MONitoring (SOLOMON) Study

Conditions
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Brain Tumor, Primary, Meningioma, Schwannoma, Pituitary Adenoma, Gliomas Benign

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for retrospective cohort Patients with radiologically diagnosed brain neoplasm of CNS WHO grade 2 or less since 1998 Asymptomatic at first visit to the hospital Patients who, based on the up-to-date knowledge, did not necessarily require immediate treatment at the first hospital visit Patients who have had two or more MRs at least 3 months apart No previous radiotherapy or radiosurgery for the brain lesion 18 years old or more Inclusion Criteria for prospective cohort Patients with newly diagnosed brain neoplasm of CNS WHO grade 2 or less Asymptomatic at first visit to the hospital Patients who, based on the up-to-date knowledge, did not necessarily require immediate treatment at the first hospital visit and who are going to take follow-up MR exams No previous radiotherapy or radiosurgery for the brain lesion 18 years old or more Patients who agree to participate by written consent Exclusion Criteria Patients who lost follow-up before the second MR exam Patients requiring immediate treatment due to worsening of symptoms within 3 months of the first MR exam Patients suspected to have other than a neoplasm at follow-up MR exams

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective cohort<br>The registry of this study was subjected to patients who were radiologically diagnosed with a non-malignant brain tumor at Seoul National University Hospital since 1998, and who have had MR re-examination after first MR exam because it was determined that immediate treatment would not be needed at the first visit to the hospital. Non-malignant brain tumors are defined as radiologically diagnosed primary intracranial neoplasms of CNS WHO grade 2 or lower and include meningioma, schwannoma, pituitary adenoma, and glioma suspected to be non-malignant. It is practically impossible to obtain informed consent from patients of this retrospective cohort, and consent was waived by the Institutional Review Board. Target population of this retrospective cohort is 1,500 tumors. | |
| Prospective cohort<br>The registry of this study was subjected to patients who were radiologically diagnosed with a non-malignant brain tumor at Seoul National University Hospital since February 2022, and who have had MR re-examination after first MR exam or will be re-examined because it was determined that immediate treatment would not be needed at the first visit to the hospital. Non-malignant brain tumors are defined as radiologically diagnosed primary intracranial neoplasms of CNS WHO grade 2 or lower and include meningioma, schwannoma, pituitary adenoma, and glioma suspected to be non-malignant. The cohort will consists of patients who agree to participate with written consent. Target population of this prospective cohort is 1,500 tumors. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor volume in each MRI | Measured tumor volume in each MRI | within 15 years after enrollment | 
| T2 signal intensity of tumor in each MRI | T2 signal intensity of tumor as a ratio to contralateral white matter | within 15 years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth rate of tumor volume between MR exams (absolute volume) | Tumor volume changed on average per year | within 15 years after enrollment | 
| Growth rate of tumor volume between MR exams (volume ratio) | Percentage of tumors that change on average per year | within 15 years after enrollment | 
| Number of patients who eventually received treatment | Number of patients who eventually received treatment, such as surgery, radiosurgery, radiotherapy, or hormonal therapy. | within 15 years after enrollment | 
| Pre-treatment follow-up period for patients who eventually received treatment | Pre-treatment follow-up period for patients who eventually received treatment, such as surgery, radiosurgery, radiotherapy, or hormonal therapy. | within 15 years after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-malignant brain tumor, Benign brain tumor, Meningioma, Schwannoma, Pituitary adenoma, Benign glioma