Solid Tumor MalignancyARCNCT07706842
Ataraxis Real-World Clinical Outcomes Registry Linking AI-Based Pathology Scores to Patient Outcomes
An observational study of Solid Tumor Malignancy and Breast Cancer, run by Ataraxis AI, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancy, Breast Cancer
- What is being tested?
- Ataraxis testing
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to Dec 2038
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Conditions
- Solid Tumor Malignancy, Breast Cancer
- Being tested
- Ataraxis testing
- Keywords
- breast cancer, artificial intelligence, registry, digital pathology
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ataraxis testingDiagnostic test
Ataraxis AI's digital pathology-based artificial intelligence (AI) testing, ordered as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Ataraxis testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (2)
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.
Measured: 10 years
Shared registry infrastructure supporting downstream independent research
Leverage the shared registry infrastructure to support downstream independent research by contributing site-investigators.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start31 Oct 2026 (estimated)
- Primary completionOct 2038 (estimated)
- Study completionDec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignancyStudies 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
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ataraxis AI, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Witowski, MD, PhD, Study director, Ataraxis AI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706842
- Sponsor's protocol ID
- Pro00095260
- Acronym
- ARC
- Status last verified
- Oct 2026
- First submitted
- 10 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ataraxis Real-World Clinical Outcomes: A Prospective, Multi-Site, Observational Registry Linking AI-Based Pathology Scores With Short- and Long-Term Outcomes
- ClinicalTrials.gov ID
- NCT07706842
- Acronym / sponsor ID
- ARC / Pro00095260
- Conditions
- Solid Tumor Malignancy, Breast Cancer
- Keywords
- breast cancer, artificial intelligence, registry, digital pathology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ataraxis AI, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- Oct 2038 (estimated)
- Study completion
- Dec 2038 (estimated)
- First posted
- 16 Jul 2026 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ataraxis testing | – | Diagnostic Test: Ataraxis testingAdult patients with a solid tumor malignancy undergoing Ataraxis testing as part of routine clinical care. Treatment will be at the discretion of the physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ataraxis testingAtaraxis AI's digital pathology-based artificial intelligence (AI) testing, ordered as part of routine clinical care. | Diagnostic test | Ataraxis testing |
Primary outcome
A large-scale, multi-site registry linking Ataraxis test results with short- and long-term clinical outcomes
Time frame: 10 years
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.
2 secondary outcomes
Performance and clinical utility of Ataraxis tests across diverse patient populations
Time frame: 10 years
Shared registry infrastructure supporting downstream independent research
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Jan Witowski, MD, PhD study director
Ataraxis AI
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor Malignancy and Breast Cancer, run by Ataraxis AI, Inc..
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 5 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Halle Hall (+1 (646) 832-2265, arcregistry@ataraxis.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A large-scale, multi-site registry linking Ataraxis test results with short- and long-term clinical outcomes (time frame: 10 years). 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 6 Oct 2026.