Infectious DiseaseNCT05013944
AnovaOS Network Powered Patient Registry
An observational study of Infectious Disease and Neoplasms, run by Anova Enterprises, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease, Neoplasms, Diseases of the Blood and Blood-Forming Organs and Certain Disorders Involving the Immune Mechanism (D50-D89)
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Aug 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Anova Enterprises, Inc.
Arlington Heights, Illinois, 60005
Martin Walsh, 224-218-2408, info-us@anovaevidence.com
Christopher Beardmore
About this study
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.
Read the 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.
- 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
- Keywords
- infectious disease, cancer/oncology, neurology, immunology, cardiology
- Medical subject headings
- Communicable Diseases, Neoplasms, Metabolic Diseases, Mental Disorders, Nervous System Diseases, Eye Diseases, Ear Diseases, Respiration Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 5 years
Assess Clinical, Cost and/or Comparative Effectiveness
Determining clinical effectiveness, cost effectiveness, or comparative effectiveness of a test or a treatment;
Measured: 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;
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Sep 2021
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Anova Enterprises, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Walsh, Study director, Anova Enterprises, IncChristopher Beardmore, Principal investigator, Anova Enterprises, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013944
- Sponsor's protocol ID
- ANOVA-001-NPPR
- Status last verified
- Jan 2024
- First submitted
- 18 Aug 2021
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AnovaOS Network Powered Patient Registry
- ClinicalTrials.gov ID
- NCT05013944
- Acronym / sponsor ID
- ANOVA-001-NPPR
- 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
- Keywords
- infectious disease, cancer/oncology, neurology, immunology, cardiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Anova Enterprises, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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;
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;
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;
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Further Registry InformationLink provided by the sponsor.
- Registry Sign upLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Walsh study director
Anova Enterprises, Inc
Christopher Beardmore principal investigator
Anova Enterprises, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disease and Neoplasms, run by Anova Enterprises, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Beardmore (+1 (224) 218-2408, chris@anovaevidence.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess Natural history (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.