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RecruitingNCT05013944Updated Jan 30, 2024

AnovaOS Network Powered Patient Registry

An observational study in Infectious Disease, Neoplasms and Diseases of the Blood and Blood-Forming Organs and Certain Disorders Involving the Immune Mechanism (D50-D89), sponsored by Anova Enterprises, Inc. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by Anova Enterprises, Inc · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Sep 2021; still recruiting 5 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100,000
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Communicable Diseases

626 studies on the registry are indexed under Communicable Diseases; 128 are open to participants now.

This study's planned enrollment of 100,000 is above the median of 200 across 228 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

This is the only study on the registry with Anova Enterprises, Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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;

    Time frame: 5 years

  2. Assess Clinical, Cost and/or Comparative Effectiveness

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

    Time frame: 5 years

  3. 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;

    Time frame: 5 years

  4. 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.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Anova Enterprises, Inc.
    Arlington Heights, Illinois 60005, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2021 (actual). Primary completion is estimated for Aug 2025, 47 months after the start.

Of 142 observational studies under Communicable Diseases, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 94. This study's planned 47 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2021
First posted
Aug 20, 2021
StartActual
Sep 1, 2021
Primary completionEst.
Aug 31, 2025
CompletionEst.
Aug 31, 2026
Last update
Jan 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05013944
Lead sponsor
Anova Enterprises, Inc
Responsible party
Sponsor
First posted
Aug 20, 2021
Start date
Sep 1, 2021
Primary completion
Aug 31, 2025 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Jan 30, 2024

Study contacts

Christopher Beardmore
Contact
chris@anovaevidence.com
+1 (224) 218-2408
Martin Walsh
study director · Anova Enterprises, Inc
Christopher Beardmore
principal investigator · Anova Enterprises, Inc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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