AnovaOS Network Powered Patient Registry

NCT05013944 | Recruiting

• 1 other identifier: ANOVA-001-NPPR
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infectious Disease; Neoplasms; Diseases of the Blood and Blood-Forming Organs and Certain Disorders Involving the Immune Mechanism (D50-D89); Endocrine, Nutritional and Metabolic Diseases (E00-E89); Mental and Behavioural Disorders; Diseases of the Nervous System; Diseases of the Eye and Adnexa; Diseases of the Ear and Mastoid Process; Diseases of the Circulatory System; Diseases of the Respiratory System; Diseases of the Digestive System; Diseases of the Skin and Subcutaneous Tissue; Diseases of the Musculoskeletal System and Connective Tissue; Diseases of the Genitourinary System; Pregnancy, Childbirth and the Puerperium; Certain Conditions Originating in the Perinatal Period; Congenital Malformations, Deformations and Chromosomal Abnormalities (Q00-Q99); Symptoms, Signs and Abnormal Clinical and Laboratory Findings, Not Elsewhere Classified; Injury, Poisoning and Certain Other Consequences of External Causes; External Causes of Morbidity and Mortality; Factors Influencing Health Status and Contact With Health Services

Keywords

infectious disease, cancer/oncology, neurology, immunology, cardiology

Outcome Measures

Primary Outcomes (4)

• Assess Natural history

  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

  Determining clinical effectiveness, cost effectiveness, or comparative effectiveness of a test or a treatment;

  5 years

• Assess Safety

  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

  Measuring or improving quality of care, including conducting programs to measure and/or improve the practice of medicine and/or public health.

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subjects who are unable to understand the protocol or unable to provide legally effective informed consent

Sponsors & Collaborators

• Anova Enterprises, Inc: lead

Study Sites (1)

Anova Enterprises, Inc.

Arlington Heights, Illinois, 60005, United States

RECRUITING

Related Links

• Further Registry Information
• Registry Sign up

MeSH Terms

Conditions

Communicable Diseases; Neoplasms; Metabolic Diseases; Mental Disorders; Nervous System Diseases; Eye Diseases; Ear Diseases; Respiration Disorders; Digestive System Diseases; Skin Diseases; Urogenital Diseases; Congenital Abnormalities; Chromosome Aberrations; Wounds and Injuries; Poisoning

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Diseases; Skin and Connective Tissue Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chemically-Induced Disorders

Study Officials

• Martin Walsh

  Anova Enterprises, Inc

  STUDY DIRECTOR

• Christopher Beardmore

  Anova Enterprises, Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Beardmore

CONTACT

+1 (224) 218-2408; chris@anovaevidence.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 20, 2021
• Study Start: September 1, 2021
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

US (1)