Wearable Devices and Biomarkers Project (Healthiomics)

August 2, 2023 updated by: CureScience

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Recruiting
        • CureScience Institute
        • Contact:
          • Shashaanka Ashili, PhD
        • Principal Investigator:
          • Feng Lin, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specimen and data storage
Time Frame: 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.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specimen and data analysis
Time Frame: 4 years
To perform multi-modality analysis of specimens for biomarker discovery.
4 years
Collaboration
Time Frame: 4 years
To make specimens and data available to collaborating investigators performing IRB-approved research of cancer or neurological disorders.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CureScience

Investigators

  • Principal Investigator: Feng Lin, MD PhD, CureScience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 11, 2021

First Submitted That Met QC Criteria

October 24, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSI-01-0706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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