An observational study in Brain Cancer, Neurological Disorder and Neurological Cancer, sponsored by CureScience. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by CureScience · Observational
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's planned enrollment of 3,500 is above the median of 100 across 380 observational studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →This is the only study on the registry with CureScience as lead sponsor.
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Potential participants will be referred to the study by a medical provider. Participants may be of sex/gender, race, or ethnic background. Participants must have the capacity to consent, or have a legally authorized representative willing to consent.
Participant is characterized by at least one of the following criteria:
Exclusion Criteria:
This cohort will include patients having been diagnosed with a neurological condition.
This cohort will include patients who have not been diagnosed with a neurological disorder.
Specimen and data storage
To collect and store biological specimens (such as, but not limited to, tissue, blood, urine, cerebrospinal fluid, etc.), data from functional and anatomical imaging modalities, digital health data and clinical data from patients with cancer or neurological disorders, those who are under evaluation for a possible cancer or neurologic disorders, or healthy controls.
Time frame: 4 years
Specimen and data analysis
To perform multi-modality analysis of specimens for biomarker discovery.
Time frame: 4 years
Collaboration
To make specimens and data available to collaborating investigators performing IRB-approved research of cancer or neurological disorders.
Time frame: 4 years
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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