Observing the growth of non-malignant brain tumors
The Risk of Growth in Patients With Non-malignant Brain Tumor: SeOuL cOhort of Brain Tumor MONitoring (SOLOMON) Study
Seoul National University Hospital · NCT05254197
This study looks at how non-cancerous brain tumors grow over time in patients who don't have symptoms and aren't needing treatment, using regular MRI scans to track changes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05254197 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with non-malignant brain tumors at Seoul National University Hospital since 2001. It aims to establish a natural growth history for these tumors by conducting repeated magnetic resonance imaging (MRI) to measure tumor volume over time. The study includes both retrospective and prospective cohorts of patients who are asymptomatic and do not require immediate treatment. By analyzing the factors related to tumor growth, the study seeks to enhance understanding of non-malignant brain tumors.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with radiologically diagnosed non-malignant brain tumors who are asymptomatic and do not require immediate treatment.
Not a fit: Patients with malignant brain tumors or those who have undergone previous radiotherapy or radiosurgery for their brain lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the natural history of non-malignant brain tumors, potentially leading to improved management strategies for patients.
How similar studies have performed: While studies on non-malignant brain tumors exist, this specific approach to establishing a natural growth history through a prospective cohort is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (RECRUITING)
Study contacts
- Principal investigator: Chul-Kee Park, MD PhD — Seoul National University Hospital
- Study coordinator: Chul-Kee Park, MD PhD
- Email: nsckpark@snu.ac.kr
- Phone: +82220720347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Tumor, Primary, Meningioma, Schwannoma, Pituitary Adenoma, Gliomas Benign, Non-malignant brain tumor, Benign brain tumor, Pituitary adenoma