SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)

Meningioma Clinical Trial

— SOLOMON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254197
• Other study ID #: SNUH-BTR01
• Status: Recruiting
• Start date: January 1, 2001
• Est. completion date: December 31, 2035

Study information

• Verified date: June 2023
• Source: Seoul National University Hospital
• Contact: Chul-Kee Park, MD PhD
• Phone: +82220720347
• Email: nsckpark[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adenoma
• Brain Neoplasms
• Brain Tumor, Primary
• Gliomas Benign
• Meningioma
• Neurilemmoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms
• Schwannoma

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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

Outcome

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