SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)

NCT05254197 | Recruiting

• 1 other identifier: SNUH-BTR01
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Tumor volume in each MRI

  Measured tumor volume in each MRI

  within 15 years after enrollment

• 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 Outcomes (4)

• Growth rate of tumor volume between MR exams (absolute volume)

  within 15 years after enrollment

• Growth rate of tumor volume between MR exams (volume ratio)

  within 15 years after enrollment

• Number of patients who eventually received treatment

  within 15 years after enrollment

• Pre-treatment follow-up period for patients who eventually received treatment

  within 15 years after enrollment

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators defined the cohort population as adults with radiologically diagnosed non-malignant brain tumor that do not require immediate treatment who agree to participate.

You may qualify if:

• 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
• 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
• years old or more
• Patients who agree to participate by written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (3)

• 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.

  PMID: 30215565 RESULT

• 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.

  PMID: 31832214 RESULT

• 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.

  PMID: 33068429 RESULT

MeSH Terms

Conditions

Brain Neoplasms; Meningioma; Neurilemmoma; Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neuroma; Nerve Sheath Neoplasms; Endocrine Gland Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Chul-Kee Park, MD PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chul-Kee Park, MD PhD

CONTACT

+82220720347; nsckpark@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 24, 2022
• Study Start: January 1, 2001
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)