SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Brain Tumor, Primary, Meningioma, Schwannoma, Pituitary Adenoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Risk of Growth in Patients With Non-malignant Brain Tumor: SeOuL cOhort of Brain Tumor MONitoring (SOLOMON) Study
Overview
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
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.
Primary outcome measures
- Tumor volume in each MRI [Time frame: within 15 years after enrollment]
- T2 signal intensity of tumor in each MRI [Time frame: within 15 years after enrollment]
Secondary outcome measures (4)
- Growth rate of tumor volume between MR exams (absolute volume) [Time frame: within 15 years after enrollment]
- Growth rate of tumor volume between MR exams (volume ratio) [Time frame: within 15 years after enrollment]
- Number of patients who eventually received treatment [Time frame: within 15 years after enrollment]
- Pre-treatment follow-up period for patients who eventually received treatment [Time frame: within 15 years after enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Publications
- Kim JH, Dho YS, Kim YH, Lee JH, Lee JH, Hong AR, Shin CS. Developing an optimal follow-up strategy based on the natural history of nonfunctioning pituitary adenomas. J Neurosurg. 2018 Sep 14;131(2):500-506. doi: 10.3171/2018.4.JNS172148. Print 2019 Aug 1. PMID 30215565
- Behbahani M, Skeie GO, Eide GE, Hausken A, Lund-Johansen M, Skeie BS. A prospective study of the natural history of incidental meningioma-Hold your horses! Neurooncol Pract. 2019 Dec;6(6):438-450. doi: 10.1093/nop/npz011. Epub 2019 Apr 17. PMID 31832214
- Reznitsky M, Petersen MMBS, West N, Stangerup SE, Caye-Thomasen P. The natural history of vestibular schwannoma growth-prospective 40-year data from an unselected national cohort. Neuro Oncol. 2021 May 5;23(5):827-836. doi: 10.1093/neuonc/noaa230. PMID 33068429
Identifiers
NCT: NCT05254197 · SNUH-BTR01