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

NCT07706842 | Not Yet Recruiting

• 1 other identifier: Pro00095260
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Solid Tumor Malignancy; Breast Cancer

Keywords

breast cancer; artificial intelligence; registry; digital pathology

Outcome Measures

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.

  10 years

Secondary Outcomes (2)

• Performance and clinical utility of Ataraxis tests across diverse patient populations

  10 years

• Shared registry infrastructure supporting downstream independent research

  10 years

Study Arms (1)

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

Interventions

Ataraxis testing DIAGNOSTIC_TEST

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

Ataraxis testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ataraxis AI, Inc.: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor tissue obtained during the patient's standard clinical care and submitted for Ataraxis testing will be retained for potential future research related to the objectives of this registry.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jan Witowski, MD, PhD

  Ataraxis AI

  STUDY DIRECTOR

Central Study Contacts

Halle Hall

CONTACT

+1 (646) 832-2265; halle.hall@ataraxis.ai

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 16, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): August 1, 2038
• Study Completion (Estimated): December 1, 2038
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share