Clinical trial · Observational
Wearable Devices and Biomarkers Project (Healthiomics)
Study of Clinical Biomarkers in Human Health and Disease (Healthiomics)
NCT05106725CI-TRIAL-00079979unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Neurological Cancer | — | UNRESOLVED | — |
| Neurological Disorder | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Neurological patients
- description
- This cohort will include patients having been diagnosed with a neurological condition.
- label
- Control
- description
- This cohort will include patients who have not been diagnosed with a neurological disorder.
Primary outcomes (1)
- measure
- Specimen and data storage
- timeFrame
- 4 years
- description
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: 1. 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 2. Has a neurological disorder, or is under evaluation for a possible diagnosis of a neurological disorder; OR 3. 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.
References
Publications (21)
- BACKGROUNDBent 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
- BACKGROUNDBraun 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
- BACKGROUNDChen 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
- BACKGROUNDFulham 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
- BACKGROUNDGillinov 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
- BACKGROUNDGomez GG, Kruse CA. Mechanisms of malignant glioma immune resistance and sources of immunosuppression. Gene Ther Mol Biol. 2006;10(A):133-146. PMID 16810329
- BACKGROUNDHawighorst 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