- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05013944
AnovaOS Network Powered Patient Registry
Study Overview
Status
Conditions
- Neoplasms
- Infectious Disease
- External Causes of Morbidity and Mortality
- Pregnancy, Childbirth and the Puerperium
- 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
- 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
- Factors Influencing Health Status and Contact With Health Services
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christopher Beardmore
- Phone Number: +1 (224) 218-2408
- Email: chris@anovaevidence.com
Study Locations
-
-
Illinois
-
Arlington Heights, Illinois, United States, 60005
- Recruiting
- Anova Enterprises, Inc.
-
Contact:
- Martin Walsh
- Phone Number: 224-218-2408
- Email: info-us@anovaevidence.com
-
Principal Investigator:
- Christopher Beardmore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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
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
Sponsor
Investigators
- Study Director: Martin Walsh, Anova Enterprises, Inc
- Principal Investigator: Christopher Beardmore, Anova Enterprises, Inc
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Pathologic Processes
- Respiratory Tract Diseases
- Disease Attributes
- Genetic Diseases, Inborn
- Poisoning
- Infections
- Communicable Diseases
- Nervous System Diseases
- Congenital Abnormalities
- Hematologic Diseases
- Digestive System Diseases
- Metabolic Diseases
- Chromosome Disorders
- Chromosome Aberrations
- Respiration Disorders
- Urogenital Diseases
Other Study ID Numbers
- ANOVA-001-NPPR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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