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Идёт набор NCT05254197

SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)

— Наблюдательное Brain Tumor, Primary Meningioma Schwannoma Pituitary Adenoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Brain Tumor, Primary, Meningioma, Schwannoma, Pituitary Adenoma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Tumor volume in each MRI [Срок оценки: within 15 years after enrollment]
  • T2 signal intensity of tumor in each MRI [Срок оценки: within 15 years after enrollment]
Вторичные конечные точки (4)
  • Growth rate of tumor volume between MR exams (absolute volume) [Срок оценки: within 15 years after enrollment]
  • Growth rate of tumor volume between MR exams (volume ratio) [Срок оценки: within 15 years after enrollment]
  • Number of patients who eventually received treatment [Срок оценки: within 15 years after enrollment]
  • Pre-treatment follow-up period for patients who eventually received treatment [Срок оценки: within 15 years after enrollment]

Критерии участия

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 1 центр
  • Seoul National University Hospital — Seoul

Публикации

  • 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
  • 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
  • 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

Идентификаторы

NCT: NCT05254197 · SNUH-BTR01

Первоисточники (государственные реестры)

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