Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Behaviors and Mental Disorders

Syndrome

Leukemia

Down Syndrome

Neoplasms by Histologic Type

Hematologic Diseases

Intellectual Disability

Neurobehavioral Manifestations

Neurologic Manifestations

Congenital Abnormalities

Abnormalities, Multiple

Chromosome Disorders

Genetic Diseases, Inborn

Lisa M. Jacola, PhD

Survivors of acute lymphoblastic leukemia (ALL) are at risk for neurocognitive deficits, reduced educational and psychosocial outcomes, and lower quality of life. Neurocognitive assessment is frequently implemented during therapy and continued into survivorship to monitor functioning and to facilitate intervention. Children with Down Syndrome (DS) are at 10 to 20-fold increased risk for leukemia. Survival rates for leukemia patients with DS are comparable to or lower than patients without DS, however, these patients are at greater risk for treatment-related toxicities. Children with preexisting neurodevelopmental conditions, including DS, are systematically excluded from neurocognitive assessment on clinical trials, contributing to a gap in the investigators understanding of outcomes in these patients with preexisting neurocognitive vulnerability. The investigators propose a novel preliminary investigation of functional outcomes in children with DS and childhood leukemia. This study has implications for future treatment of leukemia patients with DS, and may generalize to leukemia patients with other predispositions or preexisting neurodevelopmental conditions (e.g., genetic disorders, acquired brain injury, autism, and epilepsy).

Primary Objective:

* To describe neurocognitive and psychosocial outcomes in survivors of childhood leukemia with Down Syndrome using a novel assessment approach.

The investigators will recruit survivors of childhood leukemia with DS to participate in a one-time assessment of neurocognitive and psychosocial functioning. Potentially eligible families will be identified via medical record review at St. Jude Children's Research Hospital (SJCRH) and contacted to discuss study objectives, assess interest, and confirm eligibility. Eligible families will be scheduled for one study visit, estimated to last about 2.5 hours. Participants will provide informed consent prior to the start of any study procedures. Survivors who are ≥ 5 years old will complete performance-based neurocognitive measures. Caregivers (i.e., parents or legal guardians) of all participants, regardless of age, will complete ratings of executive function, behavior, and adaptive skills. Participants will be asked to identify and provide written permission to contact a secondary informant (e.g., teacher or work supervisor). Identified informants will be contacted by study team members and asked to complete behavior rating scales.

Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome

Descriptive statistics will be estimated.

St. Jude Children's Research Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Lung Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Osimertinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Osimertinib plus WBI, with Osimertinib at a dose of 80 mg once per day.

Osimertinib with WBI sequential therapy, with Osimertinib at a dose of 80 mg once per day.

Osimertinib at a dose of 80 mg once per day, and WBI

Osimertinib and whole-brain irradiation

Osimertinib at a dose of 80 mg once per day, until unacceptable adverse events or disease progression occurred. WBI could be given to patients in experimental arm at any time base on investigator's decision after treatment initiated.

Li Zhang

Yunpeng Yang

Ting Zhang

This is a prospective, randomised, positive-controlled, study to assess the neurocognitive function of upfront Osimertinib compared to whole-brain irradiation (WBI) plus Osimertinib in EGFR-mutant (Ex 19Del and L858R) NSCLC patients with symptomatic brain metastases, as well as the efficacy and safety.

Account for patients with wild type EGFR, sample attrition , incidence rate of symptomatic brain metastasis(10%) and any other reasons for screen failure rate(50%), it is esimated that 88 patients will be randomized from 5 sites. Patients will be randomized 1:1, the experimental arm is upfront Osimertinib with WBI sequential therapy, while the control arm is Osimertinib plus WBI. Osimertinib at a dose of 80 mg once per day, until unacceptable adverse events or disease progression occurred. WBI could be given to patients in experimental arm at any time base on investigator's decision after treatment initiated. Patients will be stratifed at randomization by GPA score (3.5-4 vs \<3.5) and the mutation type (Ex19Del / L858R). Patients will undergo the neurocognition, efficacy and safety assessments at baseline, and every 8 weeks until treatment is completed or discontinued. About time to brain metastases symptoms deterioration, the assessment was repeated in the first week (on site), second week (through telephone) and fourth week (on site). The rest assessment will be as well as other evaluations repeated every 8 weeks. To evaluate the correlation and predictive or prognostic value between gene dynamic changes and clinical efficacy, the tissue, plasma and cerebrospinal fluid (CSF) samples will be collected at baseline. CSF will be collected in patients with intracranial progression. Plasma will be collected in all the patients at disease progression, while tissue is optional. Also, plasma will be collected at week 8(first evaluation of efficacy).

Neurocognition in NSCLC Patients Treated With Osimertinib or Osimertinib + WBI

A Randomised Controlled Trial to Investigate the Neurocognition in EGFR-mutant Advanced Non-small Cell Lung Cancer Patients With Symptomatic Brain Metastases Treated With Osimertinib or Osimertinib Plus Whole-brain Irradiation (WBI)

Questionnaire consisting of 30 items measuring subjects general cancer symptoms and functioning

A complementary questionnaire measuring lung cancer symptoms

measured as a significant deterioration (5-point drop compared with baseline) in Hopkins Verbal Learning Test-Revised (HVLT-R) total recall at 4 months

defined as the time from randomization to the date of intracranial disease progression

defined as the time from randomization to the date of first documentary disease progression

percentage of participants with objective response in brain metastasis

percentage of participants with objective response

percentage of participants with disease control in brain metastasis

percentage of participants with disease control

defined as the time from randomization to the date of first documentary PR or CR in brain metastasis

defined as the time from randomization to the date of first documentary PR or CR

defined as the time from randomization to the date of initiate WBI

Sun Yat-sen University

Professor

Rare Diseases

Glioma

Brain Neoplasms

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Quality of Life

Neuroepithelioma

Patients with brain tumors receive an iPad with the ReMind app. The patients will use the app to train neurocognitive and compensatory skills for 3 hours per week over the course of 12 weeks (36 hours in total)

All patients will receive baseline neurocognitive and quality of life testing, followed by 3 months of the iPad-based intervention. At the end of the baseline visit, subjects will be lent an iPad to take home (or will be assisted in the installation of the ReMind app on their personal iPad) and instructed in the use of the ReMind app (and more basic iPad skills, if necessary). Subjects will review the intervention schedule (approximately 3 hours per week). Testing will be repeated 3 months after the baseline visit (i.e., immediately after the intervention) and 9 months after the baseline visit (i.e., 6 months after completion of the intervention), both time-points including a new MRI.

Device: iPad

Jennie W Taylor, MD, MPH

This pilot clinical trial studies how well an iPad-based cognitive rehabilitation program works in improving quality of life in patients with grade II-III glioma. An iPad-based cognitive rehabilitation program may help to increase patients cognitive function and quality of life, and may provide doctors with valuable information for optimizing care of patients with brain tumors.

Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients

Subject data collected or generated as the result of participation in this study may be shared with co-investigators at the Tilburg University, The Netherlands, who developed the ReMind application. This may include clinical data, pathology data, imaging data, image files, and neurocognitive assessment results. All such data will be identified only by the subject's study code. All clinical research staff from The Netherlands will maintain all study materials in compliance with applicable laws, regulations and policies.

Subjects who complete all of the intervention exercises (approximately 36 hours of intervention).

Questionnaire based measure of ease of use as a measure of feasibility.

Questionnaire based measure of user satisfaction as a measure of feasibility.

Evaluation of visual attention on the NIH Toolbox Flanker Inhibitory Control and Attention Test. The attention score ranges from 0 to 10 (10 = best performance)

Evaluation of working memory using the NIH Toolbox List Sorting Working Memory Test. Higher scores on each of these indicate higher levels of working memory.

Measurement of general quality of life (QOL) using Functional Assessment of Cancer Therapy-Brain (FACT-Br), a multi-item questionnaire. Higher ratings suggest higher QOL.

Improvement on neurocognitive testing as measured by the NIH Toolbox assessment after the intervention.

Subjective assessment of cognitive symptoms using the Functional Assessment of Cancer Therapy: Cognitive Function (FACT-Cog) questionnaire

Tilburg University

University of California, San Francisco

Skin and Connective Tissue Diseases

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

Parents in the intervention arm will receive one single-session intervention one month after completion of baseline measures. They will also complete a feasibility exit interview one month after completion of their data collection period (i.e., at 7 months).

Families in the control arm will complete measures at the exact same timepoints as those in the intervention arm but will not receive the single session intervention and will not complete the feasibility exit interview. They will receive the same information as the intervention arm via an education manual at the completion of their data collection period.

The purpose of the intervention feedback session will be twofold: 1) to provide the results of the previous assessment, and 2) to provide general psychoeducation on psychological and neurocognitive functioning and tailored cognitive and behavioral interventions based on the results in order to reduce the impact of psychological and neurocognitive deficits.

OPTIMAL-SSI

Jennifer M Rohan, PhD

Children with neurofibromatosis are more likely to have difficulties related to their psychological and neurocognitive functioning (e.g., more likely to have depression, have social difficulties, be diagnosed with ADHD). The purpose of this randomized control study is to determine how effective and useful this study's single session intervention can be in improving psychological and neurocognitive functioning. Enrolled families will consist of one parent/guardian and child. Parents and patients will complete questionnaires and objective tests at baseline, 3 months, and 6 months. Families randomized to the intervention arm will be provided with one single session intervention at Month 1 to learn about their child's testing results and receive psychoeducation and recommendations related to psychological and neurocognitive functioning.

Neurofibromatosis type 1 (NF1) is a chronic illness that is typically diagnosed during childhood and is associated with a variety of medical, psychological, and neurocognitive symptoms. NF1 is a genetic disorder, affecting about 1 in 3,000 people throughout the world. Diagnosis usually occurs in childhood and is characterized by the presence of several markers, including, but not limited to: multiple café au lait (light brown) skin spots, neurofibromas (small benign growths) on or under the skin, optic pathway gliomas, bone dysplasia, and freckling in the armpits or groin. Aside from its medical manifestations, NF1 also is associated with psychological impairment and a wide variety of neurocognitive deficits. In comparison to healthy peers and the general population, children and adolescents with NF1 have been found to have more social difficulties (e.g., more peer conflicts, fewer friends), internalizing symptoms (e.g., anxiety, depression, withdrawal), externalizing symptoms (e.g., sub-threshold or clinical symptoms consistent with ADHD such as inattention, hyperactivity, impulsivity), sleep difficulties; and worse quality of life. Additionally, while the vast majority of children with NF1 have intelligence in the average to low average range, neurocognitive deficits have been found in a range of domains including: linguistic development, verbal concept formation, reasoning, visuospatial skills, motor skills, executive function (e.g., cognitive flexibility, working memory, inhibitory control), academic achievement (e.g., reading/spelling, math), and attention. There is further support that early onset of mental health problems are associated with both future mental health problems and poorer functional outcomes in adulthood (e.g., unemployment, lower earnings, lower academic attainment).

Children with NF are more likely to be diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) than their healthy counterparts. Early detection, prevention, and intervention of psychological and neurocognitive risk may serve as a protective factor for later adverse outcomes. A meta-analysis of 175 research studies worldwide on ADHD in children ages 18 and younger found an overall pooled estimate of 7.2% of children and adolescents diagnosed with ADHD within the general population; however, ADHD is over-represented within the NF1 population, with an estimated 31 to 50% of children meeting diagnostic criteria for ADHD. Although there is limited research investigating the longitudinal impact of ADHD and NF on pediatric patients, longitudinal studies of children with ADHD document deficits in multiple domains including lower levels of education, poorer social functioning, and worse occupational outcomes. Therefore, children with comorbid diagnoses of both NF1 and ADHD or even those NF patients with sub-threshold symptoms of ADHD are likely to be at an increased risk for functional deficits later in life.

Given the general current demand for psychological services, there is a great need for brief, problem-focused psychological interventions targeting psychological and neurocognitive functioning in NF. Emerging data indicate a significant increase in mental health needs as a result of the COVID-19 pandemic, which is consistent with previous large-scale disasters and pandemics. This is a significant healthcare crisis given that prior to the pandemic in the United States, more than 11.8 million people reported having unmet mental health needs. This translates to more individuals needing mental health intervention without access; and, subsequently challenges mental health providers to expand services through novel models of intervention delivery (e.g., delivering brief problem-focused interventions based on findings from standardized assessments in unconventional settings, such as, during multidisciplinary medical visits for their medical condition). One novel delivery method of psychological services is the single-session intervention (SSI), which is defined as the intentional delivery of one visit or encounter with a clinic, provider, or program. Although there is no current research investigating the feasibility and clinical effectiveness of SSI's for pediatric patients diagnosed with NF, a meta-analysis of 50 randomized control trials of SSI's for youth with psychological problems showed a significant beneficial effect (g=0.32), with greatest effect sizes for reducing anxiety (g=0.56) and conduct problems (g=0.54). Although psychoeducation-based SSI's often were found to have a small effect size, a systematic review of 13 studies conducted between 1990 and 2018 that investigated the effects of psychoeducation-based interventions on youth with ADHD showed moderate to large effects on ADHD symptom improvement as reported by parents/teachers (g=0.787), and parent/teacher and child knowledge about ADHD (g=1.037 and g=0.721, respectively).

This is a pilot feasibility study comprising a randomized controlled trial involving patients' ages 6 to 16 years (n=50) with NF. Patients will complete standardized assessment batteries and questionnaires assessing their neurocognitive, executive, and psychological functioning. The present study will yield longitudinal patterns of neurocognitive and psychosocial outcomes across the six month period, and, collect data for preliminary development of a single session intervention. In order to gather information on how patients perform and behave in different settings, patients, parents, and teachers will also complete standardized questionnaires to gather information on psychological functioning over a six month period. Given NF is associated with psychological impairment and a wide variety of neurocognitive deficits, as well as poorer functional outcomes in adulthood, there is a great need for early detection, prevention, and intervention for this vulnerable patient population.

The proposed study has the following specific aims: Aim 1) Examine the preliminary feasibility and acceptability of using a single-session intervention focused on psychoeducation and cognitive behavioral-based recommendations related to psychological, neurocognitive, and executive functioning over six months. Hypothesis 1a: We hypothesize that families will report high acceptability for the intervention. Hypothesis 1b: It is hypothesized that families assigned to the intervention group will demonstrate improvements in both objective and subjective assessments of psychological and neurocognitive symptoms, e.g., inattention and impulsivity, as well as, executive functioning when compared to those in the control group. Aim 2) Examine descriptive and longitudinal patterns of psychological and neurocognitive factors (e.g., intellectual functioning, executive functioning, attention) across six months for the sample overall, as well as, for those in the intervention and control groups. Hypothesis 2a: It is hypothesized that a similar prevalence of ADHD for patients with NF that is seen in the literature (i.e., between 31-50%) will also be observed in our sample. Hypothesis 2b: It is hypothesized that there will be individual differences in neurocognitive patterns (e.g., executive functioning, attention) across six months in pediatric patients with neurofibromatosis (NF) with significant intra-sample variability, including differences observed between those who participated in the intervention versus those who did not. We suspect that there will be subgroups of patients who have increases in attention difficulties and executive function deficits over time, another subgroup will have decreases in attention difficulties and executive function deficits over time, and a subgroup who will have stable patterns across six months.

STUDY DESIGN

Approach:

Overview of Study Design: The current design is a pilot feasibility study comprising a randomized controlled trial involving patients ages 6 to 16 years (n=50) who are diagnosed with NF and followed by the comprehensive multidisciplinary NF clinic (Dr. Wang, Director; Dr. Rohan, Co-Director). The proposed study will contribute to new knowledge by describing trajectories of neurocognitive factors over time; as well as, examining the preliminary feasibility and effectiveness of a single-session intervention on improving psychological and neurocognitive factors such as attention and executive functioning.

This comprehensive measurement approach provides a powerful tool to address important scientific and clinically relevant questions: 1) What are the patterns of neurocognitive symptom presentation in pediatric NF?; and, how do these symptoms relate to psychosocial and health outcomes over time?; 2) How might patients and families benefit from receiving psychoeducation about neurocognitive, executive, and psychological functioning in patients with NF; as well as receiving tailored recommendations based on results of neurocognitive assessments? The use of multiple measures of neurocognitive functioning (multiple reporters and objective and subjective assessment methods), standardized questionnaires, and a single-session intervention in a pilot feasibility study of patients' ages 6 to 16 years is an innovative approach that has potential clinical utility and impact. For example, identification of neurocognitive and executive functioning deficits from multiple informants may allow development of more precise interventions in different settings for children (e.g., school, home). This approach also affords the opportunity to identify risk and protective factors in living with a chronic illness and to develop preventative and therapeutic interventions that can be delivered at the point of care to minimize barriers and maximize facilitators associated across the illness trajectory for this vulnerable patient population.

Study Procedures Recruitment and Data Collection: Eligible families seen in the Pediatric NF Clinic at VCU will be invited to participate via telephone or in person (depending on timing of clinic visit). Interested patients and parents/caregivers will provide informed consent, parental permission, and assent prior to data collection. Consented participants will be randomly allocated to the intervention (n=25) or control (n=25) groups via a computerized randomization program.

Data collection will occur at four timepoints: baseline (T0), 3-months (T1), 6-months (T2), and 7-months (T3). At T0 through T2, patients will complete standardized assessment batteries for neurocognitive functioning; and, patients, parents, and teachers will complete standardized questionnaires. All measures used within the present study are well validated and can be administered longitudinally within these time intervals with acceptable test-retest reliability. At T3, families in the intervention group will complete semi-structured qualitative interviews about the feasibility, acceptability, and desirability of the intervention.

This is a pilot feasibility study comprising a randomized controlled trial involving 50 families (i.e., parent/guardian AND child ages 6 to 16 years with NF). Consented participants will be randomly allocated to the intervention (n=25) or control (n=25) arms.

Patient randomization is assigned after baseline is completed (i.e., the patient and assessor are not aware of random assignment until after the baseline is completed). The Principal Investigator and Clinical Research Coordinator will be the only ones with access to random assignments.

Intervention Effectiveness on the Neurocognitive Functioning of Children and Adolescents With Neurofibromatosis Type 1

Preliminary Feasibility and Clinical Effectiveness of a Single-Session Intervention on the Neurocognitive Functioning of Children and Adolescents With Neurofibromatosis Type 1

Intellectual function will be assessed using the Wechsler Intelligence Scale for Children (WISC) adapted to the age of the child. The child is asked to perform a variety of intellectual tasks. Overall and subscale scores are calculated by summing the number of correct answers. Higher scores indicate better intellectual function.

Neurocognitive function will be assessed using the NIH Toolbox Cognitive Test Battery (NCTB). The NCTB is a standardized set of brief measures. Tasks are completed on a tablet and scores can be evaluated separately or as composite scores. Scores are normalized with a score of 100 being average, lower scores indicating lower neurocognitive function, and higher scores indicating higher cognitive function.

Virginia Commonwealth University

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

It takes the patient on average 15 minutes to complete the Brainlab Cognition app.

Observational study

Rupesh R Kotecha

Jessica Injiac

Rupesh Kotecha

Rupesh R Kotecha, MD

This is prospective observational registry study that will assess 1) if the neurocognitive function app (Brainlab Cognition) can be used in a widespread neuro-oncology clinic setting and 2) if patient reported quality of life parameters can be obtained electronically and integrated into clinic.

Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic

Learning and memory will be assessed by the number of correct responses (the total number of words correctly recalled). The "Verbal Recall" test will be used to measure the number of correct responses over 3 trials, the "Verbal Revision" will be used to measure the number of total correct responses, and the "Verbal Recognition" test will be used to measure number of correct responses minus the incorrect responses. Change is calculated as baseline score subtracted from post-baseline score over time.

This will be measured by the "Symbols Matching" test. Subjects will be asked to match symbols and corresponding numbers during 90 seconds. The score will be calculated by totaling the number of correct answers during the allotted time. A higher score indicates better functioning.

This will be measured by the "Words That Start With" test. The total number of words correctly generated (no numbers, no proper names) by the subject will be recorded to generate their score. A higher score indicates better functioning.

This will be measured by the "Numbers Ordering" test. This test assesses visual scanning and motor tracking requiring focused attention. Subjects are required to sequentially connect numbered dots in ascending order that are randomly scattered on the screen in consecutive order. The total time in seconds to complete the array will be recorded as the score result. A lower score indicates better functioning.

This will be measured by "Numbers and Letters Ordering" test. This test includes a divided attention component requiring mental flexibility (i.e., executive function). On this subtest, dots with numbers and letters are randomly scattered. Subjects are required to alternate between connecting numbers and letters in an ascending sequential order. Subjects will order numbers and letters from 1 to 13 and from A to M by tapping them as fast as possible in consecutive and alternating order. The total time in whole seconds to complete the array will be recorded. A lower score indicates better functioning.

Brainlab AG

Baptist Health South Florida

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Breast Neoplasms

Recurrence

Melanoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Second Primary

Neoplastic Processes

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

* MRI will be performed prior to radiation is administered
* A hippocampal sparing approach will be used when possible
* Dose will be 30 Gy in 10 fractions

* MRI will be performed prior to radiation is administered
* Radiation will be given in 1-5 fractions (dose depends on the size of the tumor that will be treated)

Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.

Whole brain radiation

Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.

Stereotactic radiation (SRS)

Ayal Aizer, MD

Ivy Ricca, BA

Ayal Aizer, MD MHS

This research study is studying two different types of radiation as treatment for brain metastases (tumors in the brain that spread from a cancer that originated elsewhere in the body)

This research study is a Phase III clinical trial. Phase III clinical trials examine the safety and effectiveness of a treatment, often comparing it to another known treatment. In this case, the investigators are specifically looking at differences between two forms of radiation treatment in terms of subsequent quality of life.

In this research study, the investigators are comparing stereotactic (focused, pinpoint) radiation (in which each tumor is narrowly targeted) against whole brain radiation (radiation targeting the entire brain) in the treatment of brain metastases. Currently whole brain radiation is the standard option for patients with 5-20 brain metastases. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, recently published studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. It also yields better quality of life in this population. It remains unknown whether stereotactic radiation improves quality of life in patients with 5-20 brain metastases relative to whole brain radiation. In this study, the investigators seek to determine which of the two methods of study treatment results in a better subsequent quality of life for patients with 5-20 brain metastases.

Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial

Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-20 Brain Metastases: A Phase III, Randomized Clinical Trial

Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)

Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic)

Radiographic assessment of first appearance of new brain metastases

Radiographic assessment of first local recurrence in the 5-20 brain metastases that were initially treated with radiation

Radiographic assessment of first appearance of radiation necrosis

Radiographic assessment of first appearance of leptomeningeal disease

Clinical assessment of first use of neurosurgical resection as salvage therapy

Clinical assessment of first use of salvage brain-directed radiation

Clinical assessment of first post-treatment seizure as assessed during routine study visits and via medical record review

Questionnaire - Karnofsky performance status

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome	NCT02859389	Leukemia Down Syndrome		-	St. Jude Children's Research Hospital
Neurocognition in NSCLC Patients Treated With Osimertinib or Osimertinib + WBI	NCT04829019	Neurocognitive	Osimertinib and... Osimertinib	18 Years -	Sun Yat-sen University
Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients	NCT02783495	Glioma	Device: iPad	18 Years -	University of California, San Francisco
Intervention Effectiveness on the Neurocognitive Functioning of Children and Adolescents With Neurofibromatosis Type 1	NCT05377008	Neurocognitive ... Mental Health I... Neurofibromatos...	OPTIMAL-SSI	6 Years - 16 Years	Virginia Commonwealth University
Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic	NCT05504681	Neurocognitive ...	Observational s...	18 Years -	Baptist Health South Florida
Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial	NCT03075072	Brain Metastase...	Whole brain rad... Stereotactic ra...	18 Years - 80 Years	Dana-Farber Cancer Institute
Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients	NCT02783495	Glioma	Device: iPad	18 Years -	University of California, San Francisco
Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome	NCT02859389	Leukemia Down Syndrome		-	St. Jude Children's Research Hospital

Spots Global Cancer Trial Database for neurocognitive