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SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05254197
Acronym
SOLOMON
Enrollment
3000
Registered
2022-02-24
Start date
2001-01-01
Completion date
2035-12-31
Last updated
2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Non-malignant brain tumor, Benign brain tumor, Meningioma, Schwannoma, Pituitary adenoma, Benign glioma

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.

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tumor volume in each MRIwithin 15 years after enrollmentMeasured tumor volume in each MRI
T2 signal intensity of tumor in each MRIwithin 15 years after enrollmentT2 signal intensity of tumor as a ratio to contralateral white matter

Secondary

MeasureTime frameDescription
Growth rate of tumor volume between MR exams (absolute volume)within 15 years after enrollmentTumor volume changed on average per year
Growth rate of tumor volume between MR exams (volume ratio)within 15 years after enrollmentPercentage of tumors that change on average per year
Number of patients who eventually received treatmentwithin 15 years after enrollmentNumber of patients who eventually received treatment, such as surgery, radiosurgery, radiotherapy, or hormonal therapy.
Pre-treatment follow-up period for patients who eventually received treatmentwithin 15 years after enrollmentPre-treatment follow-up period for patients who eventually received treatment, such as surgery, radiosurgery, radiotherapy, or hormonal therapy.

Countries

South Korea

Contacts

Primary ContactChul-Kee Park, MD PhD
nsckpark@snu.ac.kr+82220720347

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026