Clinical trial NCT05254197: SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)
Official title: The Risk of Growth in Patients With Non-malignant Brain Tumor: SeOuL cOhort of Brain Tumor MONitoring (SOLOMON) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Tumor, Primary
Meningioma
Schwannoma
Pituitary Adenoma
Gliomas Benign
Keywords: Non-malignant brain tumor
Benign brain tumor
Meningioma
Schwannoma
Pituitary adenoma
Benign glioma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators defined the cohort population as adults with radiologically diagnosed non-malignant brain tumor that do not require immediate treatment who agree to participate.

Brief summary: 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.

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

Primary outcomes:
measure: Tumor volume in each MRI
timeFrame: within 15 years after enrollment
measure: T2 signal intensity of tumor in each MRI
timeFrame: within 15 years after enrollment
Secondary outcomes:
measure: Growth rate of tumor volume between MR exams (absolute volume)
timeFrame: within 15 years after enrollment
measure: Growth rate of tumor volume between MR exams (volume ratio)
timeFrame: within 15 years after enrollment
measure: Number of patients who eventually received treatment
timeFrame: within 15 years after enrollment
measure: Pre-treatment follow-up period for patients who eventually received treatment
timeFrame: within 15 years after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chul-Kee Park, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. Print 2019 Aug 1.
citation: 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.
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.