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NCT Number: NCT05254197

SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Tumor volume in each MRI

    Time frame: within 15 years after enrollment

    Measured tumor volume in each MRI

  2. T2 signal intensity of tumor in each MRI

    Time frame: within 15 years after enrollment

    T2 signal intensity of tumor as a ratio to contralateral white matter

Secondary outcomes

  1. Growth rate of tumor volume between MR exams (absolute volume)

    Time frame: within 15 years after enrollment

    Tumor volume changed on average per year

  2. Growth rate of tumor volume between MR exams (volume ratio)

    Time frame: within 15 years after enrollment

    Percentage of tumors that change on average per year

  3. Number of patients who eventually received treatment

    Time frame: within 15 years after enrollment

    Number of patients who eventually received treatment, such as surgery, radiosurgery, radiotherapy, or hormonal therapy.

  4. Pre-treatment follow-up period for patients who eventually received treatment

    Time frame: within 15 years after enrollment

    Pre-treatment follow-up period for patients who eventually received treatment, such as surgery, radiosurgery, radiotherapy, or hormonal therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Chul-Kee Park, MD PhD

CONTACT

[email protected]

+82220720347

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: SOLOMON

Important dates

Study start
2001
Primary completion
2035
Study completion
2035
First posted
Feb 24, 2022
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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