Brain Cancer Clinical Trial
Official title:
Study of Clinical Biomarkers in Human Health and Disease (Healthiomics)
The purpose of this study is to collect clinical data, biological specimens (e.g., blood, tumor, cerebrospinal fluid, urine sample, etc.), and digital health data from patients with tumors, cancer and/or neurological disorders in order to perform research studies that could advance patient care. By collecting these specimens, the investigators plan to create and maintain a biorepository to make data and specimens available to collaborating investigators performing research to discover predictive biomarkers, patterns of care, and personalized treatments that could directly improve the care of our patients through focused proof-of-concept clinical trials.
For brain tumors in particular, this study will provide an important historical dataset against which to compare the addition of novel agents to standard chemoradiation. Despite advancements in surgery, radiotherapy and chemotherapy, the prognosis of malignant gliomas remains poor. Even worse is the prognosis of patients with metastatic brain tumors. However, it is recognized that a small number of brain tumor patients respond durably to specific modalities and treatment regimens and discovery of clinical, imaging, and genetic biomarkers would significantly advance the care of these patients. The development, validation, and application of prognostic biomarkers for primary and secondary brain tumors that predict patient treatment outcome and guide personalized treatment for each patient are of considerable clinical importance. Such prognostic models will allow more informed, pre-treatment decisions about patient response to specific treatments and judiciously guide stratification of patients for specific treatments and enrollment into clinical trials. Prognostic models will also provide a guide and platform for studying many other types of cancer and neurological disorders. The significance of evaluating the impact of therapy on quality of life and patient-centered outcomes is now widely acknowledged and recognized as one of several measures used to determine clinical benefit. There is increasing evidence that patient reported outcome (PRO) measures are sensitive to changes in disease and treatment characteristics. For example, more recent clinical trials for cancer are now describing the relationship between symptom-based PRO measures and traditional clinical trial endpoints (e.g., overall survival (OS) and progression free survival (PFS)). The relationships between symptoms, signs, and functions are complex, and there is a need to continue to analyze these relationships to determine what is being caused by the treatment and what is being caused by the disease. Distinguishing outcomes of normal aging from disease is also a challenge, therefore comparing results from patients without neurological disorders ("normal controls") across the spectrum will be an important component of the study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05023434 -
A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
|
||
| Terminated |
NCT01902771 -
Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
|
Phase 1 | |
| Completed |
NCT04114786 -
3D Printed Mask for GBM and Brain Mets
|
N/A | |
| Recruiting |
NCT04367779 -
Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
|
||
| Recruiting |
NCT06058988 -
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
|
Phase 2 | |
| Completed |
NCT02852655 -
A Pilot Surgical Trial To Evaluate Early Immunologic Pharmacodynamic Parameters For The PD-1 Checkpoint Inhibitor, Pembrolizumab (MK-3475), In Patients With Surgically Accessible Recurrent/Progressive Glioblastoma
|
Phase 1 | |
| Completed |
NCT02911155 -
Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
|
||
| Completed |
NCT01650922 -
Molecular Genetic Studies of Childhood Brain Tumors and Blood Samples
|
N/A | |
| Completed |
NCT00329589 -
A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients
|
Phase 1 | |
| Completed |
NCT00505141 -
Urban Environmental Exposures and Childhood Cancer
|
N/A | |
| Completed |
NCT00504660 -
6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients
|
Phase 2 | |
| Completed |
NCT00979810 -
Image-Guided Stereotactic Biopsy of High Grade Gliomas
|
N/A | |
| Recruiting |
NCT04899908 -
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
|
Phase 2 | |
| Active, not recruiting |
NCT02851706 -
Natural History of and Specimen Banking for People With Tumors of the Central Nervous System
|
||
| Completed |
NCT02798406 -
Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects
|
Phase 2 | |
| Completed |
NCT01012609 -
External Beam Radiation Therapy and Cetuximab Followed by Irinotecan and Cetuximab for Children and Young Adults With Newly Diagnosed Diffuse Pontine Tumors and High-Grade Astrocytomas
|
Phase 2 | |
| Completed |
NCT00782756 -
Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
|
Phase 2 | |
| Terminated |
NCT03149575 -
VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM
|
Phase 3 | |
| Completed |
NCT01974804 -
Assessment of Early Treatment Response by Diffusion and Perfusion MRI in Patients With Brain Metastasis
|
||
| Withdrawn |
NCT01320787 -
18-F-Fluoroacetate as PET Imaging Agent
|
Phase 1 |