ClinicalTrials.gg
RecruitingNCT05254197SOLOMONUpdated Dec 3, 2024

SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)

An observational study in Brain Tumor, Primary, Meningioma and Schwannoma, sponsored by Seoul National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-03.

Primary conditionPituitary NeoplasmsRegistry: Brain NeoplasmsReclassifiedWhy we changed it
Registry
Brain Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pituitary Neoplasms
Why
  1. The study's listed conditions name Pituitary Neoplasms, a narrower term within Brain Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Seoul National University Hospital · Observational

From the registry’s dates

  • Started Jan 2001; still recruiting 25 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Pituitary Neoplasms with a site in Korea, Republic of — 1 open to participants now, 1 under way, none of them phase 3. Pituitary Neoplasms · Korea, Republic of.

Started
2001
the only one that year
Observational
3 of 11
1 open now
Registered
11th of 11
by date
Lead sponsor
4 of 11
Seoul National University Hospital

Among the 11 studies in Pituitary Neoplasms with a site in Korea, Republic of, this one is the only one that started in 2001, is one of 3 observational ones, and was the 11th registered.

Pituitary Neoplasms

200 studies on the registry are indexed under Pituitary Neoplasms; 51 are open to participants now.

Browse Pituitary Neoplasms studies →

Open to participants now

1 of the 11 studies in Pituitary Neoplasms with a site in Korea, Republic of is open now.

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 36 Pituitary Neoplasms studies recruiting now, 14 (39%) set no upper age limit and 10 (28%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Pituitary Neoplasms with a site in Korea, Republic of, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

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

Browse trials for

Keywords

  • Non-malignant brain tumor
  • Benign brain tumor
  • Meningioma
  • Schwannoma
  • Pituitary adenoma
  • Benign glioma
04

In context

Pituitary Neoplasms Reclassified

200 studies on the registry are indexed under Pituitary Neoplasms; 51 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 163 across 74 observational studies indexed under Pituitary Neoplasms.

Browse Pituitary Neoplasms studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Compared within Pituitary Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

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
06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Target follow-up
15 Years
Patient registry
Yes

Groups and cohorts

  • 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.

07

What researchers measure

Primary outcomes

  1. Tumor volume in each MRI

    Measured tumor volume in each MRI

    Time frame: within 15 years after enrollment

  2. T2 signal intensity of tumor in each MRI

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

    Time frame: within 15 years after enrollment

Secondary outcomes

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

    Tumor volume changed on average per year

    Time frame: within 15 years after enrollment

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

    Percentage of tumors that change on average per year

    Time frame: within 15 years after enrollment

  3. Number of patients who eventually received treatment

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

    Time frame: within 15 years after enrollment

  4. 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.

    Time frame: within 15 years after enrollment

08

Study locations

1 of 1 sites recruiting
09

References and documents

Publications

  • 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. Erratum In: J Neurosurg. 2019 Nov 8;132(2):672. doi: 10.3171/2019.10.JNS172148a. PubMed 30215565 ↗
  • 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. PubMed 31832214 ↗
  • 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. PubMed 33068429 ↗

Individual participant data

Plan to share: No — We have no plan to share our individual participant data because is is not permitted by the Institutional Review Board.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2001 (actual). Primary completion is estimated for Dec 2035, 419 months after the start.

Of 33 observational studies under Pituitary Neoplasms, half reached primary completion within 163 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 349. This study's planned 419 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2022
First posted
Feb 24, 2022
StartActual
Jan 1, 2001
Primary completionEst.
Dec 31, 2035
CompletionEst.
Dec 31, 2035
Last update
Dec 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05254197
Responsible party
Chul-Kee Park (Professor, Seoul National University Hospital) — Principal investigator
First posted
Feb 24, 2022
Start date
Jan 1, 2001
Primary completion
Dec 31, 2035 (estimated)
Completion
Dec 31, 2035 (estimated)
Last update
Dec 3, 2024

Study contacts

Chul-Kee Park, MD PhD
Contact
nsckpark@snu.ac.kr
+82220720347
Chul-Kee Park, MD PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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