Neoplasms

Nervous System Diseases

All Conditions

Rare Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Oculocerebral Syndrome With Hypopigmentation

Brain Tumor, Childhood

Patients newly diagnosed with CNS tumours in children younger than 18 y/o, who were under in-patient treatment, were labeled as candidate cases in the CNOG-MC001 cohort for reviewing.

It is mandatory that patients recieve surgical treatment for pathological diagnosis of CNS tumours in enrolled patients. Surgical resection of tumours could be regarded as total / subtotal / partial resection and biopsy.

Tumour resection

Jie MA, M.D., Ph.D.

Tumours of central nervous system (CNS) is the most common type of solid tumour in childhood. In China, there is limited epidemiology information. Released data from Chinese CDC did not include types of CNS tumours and geographic contribution. As the Children's Neuro-Oncology Group (CNOG) was established in China in May 2017, it makes studies from multiple centers in children's brain tumors become practical. This retrospective cross-sectional study was aligned on CNOG annual meeting in 2018 and research group was named as CNOG-MC001 (MC, multicenter) collaborative group.

CNS tumours are mostly seen solid tumours in childhood , as the second common malignancy following leukemia in children. The annual age-standardized incidence rate per 1,000,000 person-years (ASR) of CNS tumour in international children's cancer incidence study is 20-30. In Asia, ASR of paediatric CNS tumours is around 15.0-24.9 in Japan, Korea, Singapore. For Chinese races including mainland of China, Taiwan and Hong Kong, ASRs of paediatric CNS tumour are 15.0, 17.4 and 23.8.

In 2017 in Shanghai, Children's Neuro-Oncology Group (CNOG) was found in 5th CSPN (Chinese Society of Pediatric Neurosurgery) / 9th CPNF (China Pediatric Neurosurgery Forum) conference, with 35 founding member institutions and 30 founding observation member institutions in mainland of China. Based on this progress, national wide registry (CNOG-MC001) was settled to obtain basic information about CNS tumour cases, combined with available epidemiology data from publications to assess current medical situation on paediatric CNS tumours in China. The protocol of CNOG-MC001 was aligned by CSPN and CNOG member institutions in CNOG annual meeting in 2018 and the study ofiicially started right after the meeting on 20181027.

The first step of this study is a national wide pre-survey to all 35 CNOG member institutions and other 22 CSPN members. The pre-survey data sheet included number of annual surgically treated paediatric CNS tumour cases (age ranging from 0 to 18 years old, classified by WHO Classification of Tumours of the Central Nervous System 2016 version), to assess the proper sites to be involved in this study. After retrieving the pre-survey results, large-scale, detailed case data sheets will be sent to participating institutions as members of CNOG-MC001 collaborative group.

National Wide Cross-sectional Study in Paediatric Central Nervous System Tumours in China -- the CNOG-MC001 Registry

Retrospective, Multi-center Cross-sectional Study on Paediatric Central Nervous Systerm Tumours by CNOG-MC001 Collaborative Group

Baseline information including gender, age, and institutional geographic data are required for epidemiology analysis.

Tumour type according to 2016 edition of the World Health Organization (WHO) Classification of Tumours of the Central Nervous System (CNS) is mandatory for epidemiology analysis.

Available overall survival data with post surgery treatments records of enrolled cases is preferred but not mandatory for outcome analysis.

Progression free survival data is preferred but not mandatory for outcome analysis.

CNOG-MC001 Collaborative Group

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Director of Dept Pediatric Neurosurgery

Immune System Diseases

Hypersensitivity

The biological specimens (hereafter referred to as 'tissue') and/or images to be used in this trial must be collected from patients who are male or female and ≥ 19 years of age, and the patient is suspected to have a brain tumor and has been scheduled for neurosurgery with a potential tumor resection. There will be up to three (3) tissue sample types assessed for each participant: 1- center-of-tumor, 2- normal tissue (collected from inevitable standard resection), and 3- margin tissue. Tissues will be removed as part of the standard neurosurgical procedure. Resected tissue will be cleaned, stained, and imaged ex-vivo using cCeLL. Image recordings of sample tissue using cCeLL - Ex vivo are taken and the obtained data is stored.

Neoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo.

cCeLL - Ex vivo

Kyungmin Hwang

Heejoon Um

Sunit Das, PhD, MA, BA

Sunit Das, MD, PhD, MA, BA

Shin-Hyuk Kang, MD, M.M.Sc, PhD

The goal of this clinical trial is to determine if cCeLL imaging is as accurate as standard biopsy practices for brain tumor surgeries. The main question\[s\] it aims to answer are:

* Is it as accurate as standard biopsy practices?
* Can it be performed faster than standard biopsy practices?

Participants will consent to having their tumor tissue assessed by both cCeLL and standard biopsy procedures. There are no additional participation requirements beyond the tumor removal surgery.

The usual practice for imaging brain tumor tissue during this type of operation, is to remove tissue from a suspicious lesion and send the tissue to the pathology department where pathologists perform a test called "frozen section". The frozen section test cools the tissue to give a diagnosis of the tissue sample (e.g., cancerous or normal tissue). This process may take up to 40 minutes to perform and uses a lot of resources within the hospital. The operation can only be finished after this report is available to the surgeon. After the surgery, the tissue is assessed by pathology with a test called permanent section which can give more details about the tissue assessment. Permanent section results are not available until after the surgery is complete. VPIX Medical Inc. has developed a system to image brain tumor tissue for the purpose of making a diagnosis (clinical decision) during the operation. This system uses Confocal Laser Endomicroscopy to image the removed tissue during the operation. This may be able to replace current standard 'frozen section analysis', which would decrease the resources needed to image the tissue, and provide faster results to the surgeon during the operation. The investigators are performing this study to determine if this type of imaging is as accurate as frozen section and if it can be performed faster. The tissue samples that are being assessed by the study device will be removed as part of a participant's normal surgery. This study will compare the results of the study device and the frozen section results. During the participant's surgery, only the standard test results will be used to make decisions. The images generated by cCeLL device will also be stored in a secure server outside of Canada, for the duration of the study. These images will be de-identified to protect participant privacy, and will be used to create a scientific repository.

cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis

A Prospective, Multi-centered, Assessor-blinded Clinical Performance Study to Evaluate the Sensitivity and Specificity of the Proposed Cell/Tissue Histopathology Image Processor cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis

Agreement between cCeLL - Ex vivo and frozen section reported as the sensitivity and specificity outcomes of cCeLL Ex vivo.

Time from the beginning of imaging to the completion of analysis

Time required by the blinded assessor reach a diagnosis.

Reported as a percentage. Number of non-diagnostic images divided by the total number of images taken

Number of images required by the blinded assessor reach a diagnosis.

Unity Health Toronto

Korea University Anam Hospital

Samsung Medical Center

Seoul National University Hospital

VPIX Medical

Behaviors and Mental Disorders

Symptoms and General Pathology

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Sensory motor rhythm neurofeedback: The subjects will perform 60 minutes per week for 10 weeks, with a total training time of 600 minutes. The intervention in this trial lasts for 10 weeks (1 time/week), with the goal of improving sensory motor rhythm. Since this training uses visual and auditory feedback, if patients are assigned to this group, they will be ask to wear an EEG cap with 19 electrodes. They can take a relaxed sitting posture and choose animations (e.g., puzzles, mazes, and other feedback content), and then focus on computer screen animation for training, each training time is approximately 60 minutes.

Patient should maintain their usual activity and treatment. Research assistants will weekly contact them to confirm their compliance.

In this study, baseline brain waves will be recorded for 5 minutes before each treatment, and the average value of SMR waves was used as the basis for setting the treatment threshold for the week. During the treatment, the subjects are arranged to sit in front of a computer screen with a game or animation playing. The individual focuses on the games or animations on the screen. The software will analyze the brain wave signals from the brain and convert them into visual and auditory feedback on the computer screen. Clients can learn to control brain activity and give visual and auditory feedback when a set threshold is reached

sensorimotor rhythm neurofeedback training

Insomnia is the most common sleep disorder in patients with primary brain tumors. In the past, 21.5% to 59.2% of patients with primary brain tumors suffer from insomnia symptoms. In addition to hypnotics, nonpharmacological interventions for insomnia in patients with brain tumors are still lacking. When using hypnotics may cause daytime sleepiness, cognitive impairment, and increase the risk of cancer, seeking an effective intervention is of clinical importance. Sensorimotor rhythm neurofeedback therapy has been shown to improve insomnia in different populations. However, its effect on insomnia has not been explored in patients with brain tumors. We, therefore, aim to investigate the feasibility and effect of sensorimotor rhythm neurofeedback in improving insomnia in patients with benign brain tumors after surgery and to examine the correlation between the degree of insomnia improvement and quality of life changes after receiving sensorimotor rhythm neurofeedback.

Brain tumors are mainly divided into primary and metastatic, and are further divided into benign and malignant according to the pathological type. Among them, meningioma and pituitary tumor are the top two most common primary benign brain tumors, accounting for 36.1% respectively. -54.5% and 10-15%, while the most malignant glioblastoma accounts for 45-49.1% of primary malignant brain tumors. Among them, glioblastomas are more common in men and meningiomas are more common in women.

Insomnia is the most common sleep disorder in patients with primary brain tumors. Insomnia refers to difficulty falling asleep, staying awake and unable to fall asleep while sleeping, frequently waking up during sleep period or shortening sleep time, resulting in still feeling tired after getting up and affecting daily life functions. In the past, in terms of the prevalence of insomnia, primary brain 21.5%\~59.2% of patients with tumor had insomnia symptoms, and if subdivided into benign, 46.8% of patients with primary benign brain tumor.

According to the results of the study, patients with primary brain tumors still have widespread and persistent insomnia problems after treatment, and even up to one year after surgery, there are still studies showing insomnia problems. Savard et al (2011) reported that insomnia is also a cancer A common and persistent problem among patients, the attack rate of insomnia generally decreased over time, but remained prevalent (36%) even at the end of 18 months. However, in real life, although insomnia has a high attack rate and a high burden on the family, and even affects the overall quality of life of patients, it is often not valued and treated.

Neurofeedback (NFB), also known as brain wave training, is a method to help subjects consciously control their brain waves. In order to reflect the state of brain activity, the software analyzes the measured brain waves and provides feedback signals to teach individuals to self-regulate brain waves. After repeated training, the target brain waves can be generated. When the threshold is reached, it will give visual and auditory feedback. Neurofeedback has been used clinically in many diseases and healthy individuals that cannot be effectively treated with drugs, such as insomnia, ADHD, epilepsy, fibromyalgia, depression, anxiety, pain, learning and memory, etc. For insomnia, the use of neurofeedback therapy can help people who usually take an hour or so to fall asleep fall asleep faster.

According to Lambert-Beaudet et al. (2021) reviewing the latest research on the use of neurofeedback in the treatment of insomnia, the enhancement of sensorimotor rhythm neurofeedback to improve insomnia was the most included and confirmed to improve insomnia. And multiple studies have confirmed that sensorimotor rhythm neurofeedback enhancement training can lead to increased sleep spindle density, decreased sleep onset latency, increased total sleep time, and decreased wake-up after falling asleep. Therefore, sensorimotor rhythm neurofeedback enhancement training can be an effective method for non-drug intervention in the treatment of insomnia. Given that the effects of sensorimotor rhythm neurofeedback training on insomnia have not been studied in patients with benign brain tumors after surgery, further studies in this group are warranted.

Effects of SMR Neurofeedback on Insomnia in Patients With Benign Brain Tumors

Effects of Sensorimotor Rhythm Neurofeedback on Insomnia in Patients With Benign Brain Tumors Underwent Surgery

The ISI consists of seven items, and each item can be rated from 0 to 4, resulting in total score ranging from 0 to 28, with higher scores indicating greater insomnia severity. A cutoff score of \> 7 is used to diagnose subthreshold insomnia.

Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.

Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.

Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).

Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.

The M.D. Anderson Syndrome Inventory-Taiwan Form (MDASI-Taiwan Form) is mainly used to assess the severity of various cancer symptoms in cancer patients due to cancer disease itself and various cancer treatments. The item, divided into two parts, the first part is the severity of cancer symptoms (symptom intensity): 0 points means no symptoms, 10 points means the most severe degree you can imagine, 1-3 points are mild, 4-6 points are mild Moderate, a score of 7 or more is severe; Part II: Severity of cancer symptoms that interfere with the functioning of life activities (life interference intensity): 0 means no interference, 10 means complete interference, and 1-3 means mild , 4 - 6 as moderate, 7 or more as severe.

Depression will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of depression. The total score should be multiplied by 2 range from 0-42, if score\>9 is associated with depression. The higher score means more severe depression

Anxiety will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of anxiety. The total score should be multiplied by 2 range from 0-42, if score\>7 is associated with anxiety. The higher score means more severe anxiety.

Stress will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of stress. The total score should be multiplied by 2 range from 0-42, if score\>14 is associated with anxiety. The higher score means more severe stress

Taipei Medical University

Associate Professor

Eye Diseases

Optic Nerve Neoplasms

Peripheral Nervous System Neoplasms

Cranial Nerve Diseases

Optic Nerve Diseases

25 Gy delivered in 5 fractions of 5 Gy per fraction

CyberKnife Radiosurgery

Shermian Woodhouse, MD

The purpose of this study is to find out what effects (good and bad) CyberKnife stereotactic radiosurgery has on tumors near the critical structures of the eye (optic apparatus).

The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife ® can deliver tumor ablating doses of radiation to perioptic lesions safely and effectively while sparing the adjacent optic apparatus and normal brain tissues from receiving damaging doses of radiation.

The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.

A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors

A Phase II Study of Fractionated CyberKnife Stereotactic Radiosurgery to Perioptic Tumors

To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.

Community Cancer Center, Normal, Illinois

Gland and Hormone Related Diseases

Glioma

Meningioma

Adenoma

Pituitary Diseases

Neurilemmoma

Pituitary Neoplasms

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Hypothalamic Diseases

Endocrine System Diseases

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Neuroendocrine Tumors

Neuroma

Nerve Sheath Neoplasms

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Schwannoma

Neuroepithelioma

Neuroendocrine Tumor

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.

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.

Chul-Kee Park, MD PhD

Ho Kang, MD

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.

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.

SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)

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

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

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

Percentage of tumors that change on average per year

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

Pre-treatment follow-up period for patients who eventually received treatment, such as surgery, radiosurgery, radiotherapy, or hormonal therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
National Wide Cross-sectional Study in Paediatric Central Nervous System Tumours in China -- the CNOG-MC001 Registry	NCT04351035	Tumors, Central... Pediatric Brain... Malignant Brain... Benign Brain Tu...	Tumour resectio...	- 18 Years	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis	NCT06098248	Benign Brain Tu... Malignant Brain...	cCeLL - Ex vivo	19 Years -	VPIX Medical
Effects of SMR Neurofeedback on Insomnia in Patients With Benign Brain Tumors	NCT05518942	Benign Brain Tu... Neurofeedback Insomnia	sensorimotor rh...	20 Years - 65 Years	Taipei Medical University
Effects of SMR Neurofeedback on Insomnia in Patients With Benign Brain Tumors	NCT05518942	Benign Brain Tu... Neurofeedback Insomnia	sensorimotor rh...	20 Years - 65 Years	Taipei Medical University
A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors	NCT02225197	Tumor, Benign, ...	CyberKnife Radi...	21 Years -	Community Cancer Center, Normal, Illinois
National Wide Cross-sectional Study in Paediatric Central Nervous System Tumours in China -- the CNOG-MC001 Registry	NCT04351035	Tumors, Central... Pediatric Brain... Malignant Brain... Benign Brain Tu...	Tumour resectio...	- 18 Years	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)	NCT05254197	Brain Tumor, Pr... Meningioma Schwannoma Pituitary Adeno... Gliomas Benign		18 Years -	Seoul National University Hospital

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