SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)

Recruiting

• Conditions: Brain Tumor, Primary; Schwannoma; Meningioma; Gliomas Benign; Pituitary Adenoma

• Registration Number: NCT05254197
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2001-01-01
• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-14
• Study First Posted: 2022-02-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-30
• Last Update Posted: 2024-12-03
• Primary Completion: 2035-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor volume in each MRI	within 15 years after enrollment	Measured tumor volume in each MRI
T2 signal intensity of tumor in each MRI	within 15 years after enrollment	T2 signal intensity of tumor as a ratio to contralateral white matter

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of