Wearable Devices and Biomarkers Project (Healthiomics)

NCT05106725 | Recruiting

• 1 other identifier: CSI-01-0706
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Cancer; Neurological Disorder; Neurological Cancer

Keywords

wearables; digital health; biospecimens

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Secondary Outcomes (2)

• Specimen and data analysis

  4 years

• Collaboration

  4 years

Study Arms (2)

Neurological patients

This cohort will include patients having been diagnosed with a neurological condition.

Control

This cohort will include patients who have not been diagnosed with a neurological disorder.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• CureScience: lead

Study Sites (1)

CureScience Institute

San Diego, California, 92121, United States

RECRUITING

Related Publications (21)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Hewitt R, Watson PH, Dhir R, Aamodt R, Thomas G, Mercola D, Grizzle WE, Morente MM. Timing of consent for the research use of surgically removed tissue: is postoperative consenting acceptable? Cancer. 2009 Jan 1;115(1):4-9. doi: 10.1002/cncr.23999. No abstract available.

  PMID: 19090013 BACKGROUND

• Hoskin PJ, Saunders MI, Goodchild K, Powell ME, Taylor NJ, Baddeley H. Dynamic contrast enhanced magnetic resonance scanning as a predictor of response to accelerated radiotherapy for advanced head and neck cancer. Br J Radiol. 1999 Nov;72(863):1093-8. doi: 10.1259/bjr.72.863.10700827.

  PMID: 10700827 BACKGROUND

• Huhn SL, Mohapatra G, Bollen A, Lamborn K, Prados MD, Feuerstein BG. Chromosomal abnormalities in glioblastoma multiforme by comparative genomic hybridization: correlation with radiation treatment outcome. Clin Cancer Res. 1999 Jun;5(6):1435-43.

  PMID: 10389929 BACKGROUND

• Huisman TA, Schwamm LH, Schaefer PW, Koroshetz WJ, Shetty-Alva N, Ozsunar Y, Wu O, Sorensen AG. Diffusion tensor imaging as potential biomarker of white matter injury in diffuse axonal injury. AJNR Am J Neuroradiol. 2004 Mar;25(3):370-6.

  PMID: 15037457 BACKGROUND

• Kmiecik J, Poli A, Brons NH, Waha A, Eide GE, Enger PO, Zimmer J, Chekenya M. Elevated CD3+ and CD8+ tumor-infiltrating immune cells correlate with prolonged survival in glioblastoma patients despite integrated immunosuppressive mechanisms in the tumor microenvironment and at the systemic level. J Neuroimmunol. 2013 Nov 15;264(1-2):71-83. doi: 10.1016/j.jneuroim.2013.08.013. Epub 2013 Aug 31.

  PMID: 24045166 BACKGROUND

• Lin S, Yu W, Wang B, Zhao Y, En K, Zhu J, Cheng X, Zhou C, Lin H, Wang Z, Hojaiji H, Yeung C, Milla C, Davis RW, Emaminejad S. Noninvasive wearable electroactive pharmaceutical monitoring for personalized therapeutics. Proc Natl Acad Sci U S A. 2020 Aug 11;117(32):19017-19025. doi: 10.1073/pnas.2009979117. Epub 2020 Jul 27.

  PMID: 32719130 BACKGROUND

• Malmberg KJ, Ljunggren HG. Escape from immune- and nonimmune-mediated tumor surveillance. Semin Cancer Biol. 2006 Feb;16(1):16-31. doi: 10.1016/j.semcancer.2005.07.007. Epub 2005 Sep 2.

  PMID: 16140546 BACKGROUND

• Helfer JL, Wen PY, Blakeley J, Gilbert MR, Armstrong TS. Report of the Jumpstarting Brain Tumor Drug Development Coalition and FDA clinical trials clinical outcome assessment endpoints workshop (October 15, 2014, Bethesda MD). Neuro Oncol. 2016 Mar;18 Suppl 2(Suppl 2):ii26-ii36. doi: 10.1093/neuonc/nov270.

  PMID: 26989130 BACKGROUND

• Nelson BW, Allen NB. Accuracy of Consumer Wearable Heart Rate Measurement During an Ecologically Valid 24-Hour Period: Intraindividual Validation Study. JMIR Mhealth Uhealth. 2019 Mar 11;7(3):e10828. doi: 10.2196/10828.

  PMID: 30855232 BACKGROUND

• Prendergast CT, Anderton SM. Immune cell entry to central nervous system--current understanding and prospective therapeutic targets. Endocr Metab Immune Disord Drug Targets. 2009 Dec;9(4):315-27. doi: 10.2174/187153009789839219.

  PMID: 20028334 BACKGROUND

• Schmitt P, Kotas M, Tobermann A, Haase A, Flentje M. Quantitative tissue perfusion measurements in head and neck carcinoma patients before and during radiation therapy with a non-invasive MR imaging spin-labeling technique. Radiother Oncol. 2003 Apr;67(1):27-34. doi: 10.1016/s0167-8140(03)00024-0.

  PMID: 12758237 BACKGROUND

• Stehlik J, Schmalfuss C, Bozkurt B, Nativi-Nicolau J, Wohlfahrt P, Wegerich S, Rose K, Ray R, Schofield R, Deswal A, Sekaric J, Anand S, Richards D, Hanson H, Pipke M, Pham M. Continuous Wearable Monitoring Analytics Predict Heart Failure Hospitalization: The LINK-HF Multicenter Study. Circ Heart Fail. 2020 Mar;13(3):e006513. doi: 10.1161/CIRCHEARTFAILURE.119.006513. Epub 2020 Feb 25.

  PMID: 32093506 BACKGROUND

• Thomson EA, Nuss K, Comstock A, Reinwald S, Blake S, Pimentel RE, Tracy BL, Li K. Heart rate measures from the Apple Watch, Fitbit Charge HR 2, and electrocardiogram across different exercise intensities. J Sports Sci. 2019 Jun;37(12):1411-1419. doi: 10.1080/02640414.2018.1560644. Epub 2019 Jan 18.

  PMID: 30657025 BACKGROUND

Related Links

• CureScience website

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be collected leftover from clinical care procedures. These sample types may include: tissue, blood, CSF, fluids, urine, saliva, etc.

MeSH Terms

Conditions

Brain Neoplasms; Nervous System Diseases; Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases

Study Officials

• Feng Lin, MD PhD

  CureScience

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Wilburn

CONTACT

8588002873; awilburn@curescience.orgg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 4, 2021
• Study Start: October 11, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

US (1)