SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)

NCT ID: NCT05254197

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-01

Study Completion Date

2035-12-31

Brief Summary

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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

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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.

Conditions

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Brain Tumor, Primary Meningioma Schwannoma Pituitary Adenoma Gliomas Benign

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Retrospective cohort

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 1998, and who have had MR re-examination after first MR exam 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 primary intracranial neoplasms of CNS WHO grade 2 or lower and include meningioma, schwannoma, pituitary adenoma, and glioma suspected to be non-malignant. It is practically impossible to obtain informed consent from patients of this retrospective cohort, and consent was waived by the Institutional Review Board. Target population of this retrospective cohort is 1,500 tumors.

No interventions assigned to this group

Prospective cohort

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 February 2022, 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 primary intracranial neoplasms of CNS WHO grade 2 or lower and include meningioma, schwannoma, pituitary adenoma, and glioma suspected to be non-malignant. The cohort will consists of patients who agree to participate with written consent. Target population of this prospective cohort is 1,500 tumors.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chul-Kee Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chul-Kee Park, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chul-Kee Park, MD PhD

Role: CONTACT

+82220720347

Facility Contacts

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Sun Mo Nam, MD

Role: primary

+821096713692

References

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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.

Reference Type RESULT
PMID: 30215565 (View on PubMed)

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.

Reference Type RESULT
PMID: 31832214 (View on PubMed)

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.

Reference Type RESULT
PMID: 33068429 (View on PubMed)

Other Identifiers

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SNUH-BTR01

Identifier Type: -

Identifier Source: org_study_id