Wearable Devices and Biomarkers Project (Healthiomics)

Sponsor

CureScience (Other)

Overall Status

Recruiting

CT.gov ID

NCT05106725

Collaborator

(none)

3,500

Enrollment

Location

50.7

Anticipated Duration (Months)

69.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Cancer Neurological Disorder Neurological Cancer

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

3500 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 11, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Specimen and data storage [4 years]
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 Outcome Measures

Specimen and data analysis [4 years]
To perform multi-modality analysis of specimens for biomarker discovery.
Collaboration [4 years]
To make specimens and data available to collaborating investigators performing IRB-approved research of cancer or neurological disorders.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.