Clinical trial NCT05013944: AnovaOS Network Powered Patient Registry
Official title: AnovaOS Network Powered Patient Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Anova Enterprises, Inc
Sponsor class: INDUSTRY
First posted: 2021-08-20
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess Natural history
timeFrame: 5 years
measure: Assess Clinical, Cost and/or Comparative Effectiveness
timeFrame: 5 years
measure: Assess Safety
timeFrame: 5 years
measure: Measuring and/or Improving Quality of Care
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Arlington Heights
country: United States
facility: Anova Enterprises, Inc.
state: Illinois
Study officials:
affiliation: Anova Enterprises, Inc
name: Martin Walsh
role: STUDY_DIRECTOR
affiliation: Anova Enterprises, Inc
name: Christopher Beardmore
role: PRINCIPAL_INVESTIGATOR
References: