AnovaOS Network Powered Patient Registry

January 29, 2024 updated by: Anova Enterprises, Inc
The objective of this study is the development, implementation and management of a registry of patient data that captures clinically meaningful, real-world, data on the diagnosis, nature, course of infection, treatment(s) and outcomes in patients with complex disease globally.

Study Overview

Detailed Description

The AnovaOS™ Network Powered Patient Registry may be used to inform the development and conduct of clinical trials and observational studies designed to better understand, prevent, diagnose, treat, ameliorate or cure disease. The AnovaOS™ Network Powered Patient Registry may additionally be used to expedite identification and recruitment of participants for clinical trials of promising therapeutics and observational studies.

Study Type

Observational

Enrollment (Estimated)

100000

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

    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Recruiting
        • Anova Enterprises, Inc.
        • Contact:
        • Principal Investigator:
          • Christopher Beardmore

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

Probability Sample

Study Population

Real-world clinical data about patients with complex, serious or immediately life-threatening disease collected as part of the AnovaOS™ platform is important to the scientific community. These data support biopharmaceutical companies, academic researchers and other sponsors with program design and prioritization, study activation and enrolment, and study conduct to help advance promising new therapeutic approaches. Learning from real-world evidence can help inform drug development and help as our research system evolves from a traditional model to one capable of recognizing the benefits of precision medicine.

The objective of this study is the development, implementation and management of a registry of patient data that captures clinically meaningful, real-world, data on the diagnosis, nature, course of infection, treatment(s) and outcomes in on patients with complex disease globally.

Description

Inclusion Criteria:

  • 18 years old or older;
  • Confirmed positive diagnosis of disease, condition or disorder. This will be self-reported or reported by the patient's provider, advocacy group or other patient representative;
  • Laboratory or other independent means of confirmation is not required but may be confirmed in clinical trials;
  • Able to understand and willing to sign the informed consent document; or whose legal representative has given consent to participate in the research per state and Federal requirements;
  • Willing and able to complete the registry questions or have the instrument(s) completed by an informed proxy;
  • Anticipated additional follow up with the registry once per year.

Exclusion Criteria:

  • Subjects who do not meet the inclusion criteria for the study;
  • Subjects who are unable to understand the protocol or unable to provide legally effective 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Natural history
Time Frame: 5 years
Assessing natural history, including estimating the magnitude of a problem; determining the underlying incidence or prevalence rate of a condition; examining trends of disease over time; assessing service delivery and identifying groups at high risk; and describing and estimating survival;
5 years
Assess Clinical, Cost and/or Comparative Effectiveness
Time Frame: 5 years
Determining clinical effectiveness, cost effectiveness, or comparative effectiveness of a test or a treatment;
5 years
Assess Safety
Time Frame: 5 years
Measuring and monitoring safety and harm associated with the use of specific products and treatments, including conducting comparative evaluation of safety and effectiveness;
5 years
Measuring and/or Improving Quality of Care
Time Frame: 5 years
Measuring or improving quality of care, including conducting programs to measure and/or improve the practice of medicine and/or public health.
5 years

Collaborators and Investigators

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

Investigators

  • Study Director: Martin Walsh, Anova Enterprises, Inc
  • Principal Investigator: Christopher Beardmore, Anova Enterprises, Inc

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.

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)

September 1, 2021

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

August 18, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

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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