Wearable Devices and Biomarkers Project (Healthiomics)

Official title

Study of Clinical Biomarkers in Human Health and Disease (Healthiomics)

Overview

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.

Detailed description

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.

Primary outcome measures

• Specimen and data storage [Time frame: 4 years]

Secondary outcome measures (2)

• Specimen and data analysis [Time frame: 4 years]
• Collaboration [Time frame: 4 years]

Eligibility criteria

Inclusion criteria

• Participant or participant's legally authorized representative has the ability to understand and the willingness to provide a signed and dated informed consent form.
• Participant is ≥ 18 years of age.
• Participant had/has a scheduled appointment with oncology or neurosciences services at the participating medical and surgical facility.
• Participant is characterized by at least one of the following criteria:

• Has a neurological complication from any type of cancer, or is under evaluation for a possible cancer diagnosis or neurologic complication. Participant may be newly diagnosed, in relapse, or be free of disease at the time of recruitment. Participant without a confirmed cancer diagnosis is eligible.; OR
• Has a neurological disorder, or is under evaluation for a possible diagnosis of a neurological disorder; OR
• Does not meet the characteristic of either a. or b. above. This participant would be considered a "healthy control" for cancer and neurological disorders.

Exclusion criteria

• Participant or participant's legally authorized representative is unable to provide informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

United States · 1 center

• CureScience Institute — San Diego

Publications

• Bent B, Goldstein BA, Kibbe WA, Dunn JP. Investigating sources of inaccuracy in wearable optical heart rate sensors. NPJ Digit Med. 2020 Feb 10;3:18. doi: 10.1038/s41746-020-0226-6. eCollection 2020. PMID 32047863
• Braun KL, Tsark JU, Powers A, Croom K, Kim R, Gachupin FC, Morris P. Cancer patient perceptions about biobanking and preferred timing of consent. Biopreserv Biobank. 2014 Apr;12(2):106-12. doi: 10.1089/bio.2013.0083. PMID 24749877
• Chen W. Clinical applications of PET in brain tumors. J Nucl Med. 2007 Sep;48(9):1468-81. doi: 10.2967/jnumed.106.037689. Epub 2007 Aug 17. PMID 17704239
• Fulham MJ, Bizzi A, Dietz MJ, Shih HH, Raman R, Sobering GS, Frank JA, Dwyer AJ, Alger JR, Di Chiro G. Mapping of brain tumor metabolites with proton MR spectroscopic imaging: clinical relevance. Radiology. 1992 Dec;185(3):675-86. doi: 10.1148/radiology.185.3.1438744. PMID 1438744
• Gillinov S, Etiwy M, Wang R, Blackburn G, Phelan D, Gillinov AM, Houghtaling P, Javadikasgari H, Desai MY. Variable Accuracy of Wearable Heart Rate Monitors during Aerobic Exercise. Med Sci Sports Exerc. 2017 Aug;49(8):1697-1703. doi: 10.1249/MSS.0000000000001284. PMID 28709155
• Gomez GG, Kruse CA. Mechanisms of malignant glioma immune resistance and sources of immunosuppression. Gene Ther Mol Biol. 2006;10(A):133-146. PMID 16810329
• Hawighorst H, Knopp MV, Debus J, Hoffmann U, Grandy M, Griebel J, Zuna I, Essig M, Schoenberg SO, DeVries A, Brix G, van Kaick G. Pharmacokinetic MRI for assessment of malignant glioma response to stereotactic radiotherapy: initial results. J Magn Reson Imaging. 1998 Jul-Aug;8(4):783-8. doi: 10.1002/jmri.1880080406. PMID 9702878
• Heesters MA, Kamman RL, Mooyaart EL, Go KG. Localized proton spectroscopy of inoperable brain gliomas. Response to radiation therapy. J Neurooncol. 1993 Jul;17(1):27-35. doi: 10.1007/BF01054271. PMID 8120569

Identifiers

NCT: NCT05106725 · CSI-01-0706

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗