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

Ataraxis Real-World Clinical Outcomes: A Prospective, Multi-Site, Observational Registry Linking AI-Based Pathology Scores With Short- and Long-Term Outcomes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Solid Tumor Malignancy
• Intervention / Treatment: Diagnostic test: Ataraxis testing

Detailed Description

The Ataraxis Real-World Clinical Outcomes (ARC) registry is a prospective, multi-site, non-interventional, observational registry designed to capture short- and long-term clinical outcomes of patients who undergo Ataraxis testing as part of routine clinical care. Ataraxis tests generate prognostic and predictive scores from digitized hematoxylin and eosin (H&E)-stained pathology slides and baseline clinical variables. Treatment is at the discretion of the treating physician in accordance with standard of care, and participation in the registry does not change or influence treatment selection.

Following enrollment, clinical data will be collected at multiple time points for up to 10 years. Data will be captured in Ataraxis AI's Portal.

Enrollment is planned over approximately two years, with follow-up extending up to 10 years per participant. Approximately 1,000 participants will be enrolled across participating U.S. sites.

Objectives:

• Establish a large-scale, multi-site registry of patients receiving Ataraxis tests, linking test results with short- and long-term clinical outcomes to evaluate their real-world prognostic and predictive performance and clinical utility
• Evaluate the performance and clinical utility of Ataraxis tests across diverse patient populations, including molecular subtypes, treatment regimens, and demographic and geographic strata
• Leverage the adaptable registry infrastructure to support downstream independent research by contributing site-investigators

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Halle Hall; Phone Number: +1 (646) 832-2265; Email: halle.hall@ataraxis.ai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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.
• Willing and able to provide written informed consent.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ataraxis testing; Adult patients with a solid tumor malignancy undergoing Ataraxis testing as part of routine clinical care. Treatment will be at the discretion of the physician.	Diagnostic test: Ataraxis testing; Ataraxis AI's digital pathology-based artificial intelligence (AI) testing, ordered as part of routine clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years
Shared registry infrastructure supporting downstream independent research	Leverage the shared registry infrastructure to support downstream independent research by contributing site-investigators.	10 years

Collaborators and Investigators

• Sponsor: Ataraxis AI, Inc.
• Investigators: Study Director: Jan Witowski, MD, PhD, Ataraxis AI

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): August 1, 2038
• Study Completion (Estimated): December 1, 2038

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; artificial intelligence; registry; digital pathology
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: Pro00095260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No