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Ataraxis Real-World Clinical Outcomes Registry Linking AI-Based Pathology Scores to Patient Outcomes

ConditionsSolid Tumor MalignancyBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAtaraxis AI, Inc.

About this trial

The ARC Registry is a large-scale, multi-site, prospective, observational registry. All patients with a solid tumor malignancy who receive Ataraxis testing as part of routine clinical care are eligible for enrollment, which will link Ataraxis test results with short- and long-term patient outcomes to evaluate the real-world performance and clinical utility of Ataraxis tests. The ARC Registry utilizes an adaptable design, where additional Sponsor-led analyses and investigator-initiated ancillary studies can be added after the initial study is opened.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older at the time of consent.

Diagnosis of a solid tumor malignancy, confirmed histologically or cytologically.

Patient is undergoing Ataraxis testing as part of their routine clinical care.

Availability of a pathology specimen.

Disqualifiers

Unable or unwilling to provide informed consent.

Patient for whom an Ataraxis test result was not successfully generated (e.g., due to sample quality, technical failure, or any reason resulting in a non-reportable result).

Trial population

Study population will include adults (≥18 years) with a histologically or cytologically confirmed solid tumor malignancy who undergo Ataraxis testing as part of routine clinical care and have signed an informed consent. Patients will be excluded if an Ataraxis test result is not successfully generated.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ataraxis testing

    Diagnostic test

    Ataraxis AI's digital pathology-based artificial intelligence (AI) testing, ordered as part of routine clinical care.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Ataraxis testing1 intervention

Trial outcomes

Primary outcomes

1

A large-scale, multi-site registry linking Ataraxis test results with short- and long-term clinical outcomes

Establish a prospective, multi-site registry of patients receiving Ataraxis tests, linking results with clinical outcomes to evaluate the real-world prognostic and predictive performance and clinical utility of Ataraxis tests.

Time frame
10 years

Secondary outcomes

1

Performance and clinical utility of Ataraxis tests across diverse patient populations

Evaluate the performance and clinical utility of Ataraxis tests across diverse patient populations, including across molecular subtypes, treatment regimens, and demographic and geographic strata, in real-world clinical practice.

Time frame
10 years
2

Shared registry infrastructure supporting downstream independent research

Leverage the shared registry infrastructure to support downstream independent research by contributing site-investigators.

Time frame
10 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ataraxis AI, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: