Meningioma Clinical Trial
— SOLOMONOfficial title:
The Risk of Growth in Patients With Non-malignant Brain Tumor: SeOuL cOhort of Brain Tumor MONitoring (SOLOMON) Study
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.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | December 31, 2035 |
Est. primary completion date | December 31, 2035 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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. — View Citation
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. Erratum In: J Neu — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor volume in each MRI | Measured tumor volume in each MRI | within 15 years after enrollment | |
Primary | 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 | Growth rate of tumor volume between MR exams (absolute volume) | Tumor volume changed on average per year | within 15 years after enrollment | |
Secondary | Growth rate of tumor volume between MR exams (volume ratio) | Percentage of tumors that change on average per year | within 15 years after enrollment | |
Secondary | 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 | |
Secondary | 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 |
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