SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSeoul National University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 2 trial groupsGroup A: Retrospective cohort
Group B: Prospective cohort
Trial outcomes
Primary outcomes
1
Tumor volume in each MRI
Measured tumor volume in each MRI
Time frame
within 15 years after enrollment2
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 enrollmentSecondary 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 enrollment2
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 enrollment3
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 enrollment4
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 enrollmentSponsors and contacts
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Source ClinicalTrials.gov