Ataraxis Real-World Clinical Outcomes Registry Linking AI-Based Pathology Scores to Patient Outcomes (ARC)
10. juli 2026 oppdatert av: Ataraxis AI, Inc.
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Observasjonsmessig
Registrering (Antatt)
1000
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Halle Hall
- Telefonnummer: +1 (646) 832-2265
- E-post: halle.hall@ataraxis.ai
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Ataraxis AI's digital pathology-based artificial intelligence (AI) testing, ordered as part of routine clinical care.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
A large-scale, multi-site registry linking Ataraxis test results with short- and long-term clinical outcomes
Tidsramme: 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.
|
10 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Performance and clinical utility of Ataraxis tests across diverse patient populations
Tidsramme: 10 years
|
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
Tidsramme: 10 years
|
Leverage the shared registry infrastructure to support downstream independent research by contributing site-investigators.
|
10 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Jan Witowski, MD, PhD, Ataraxis AI
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
31. juli 2026
Primær fullføring (Antatt)
1. august 2038
Studiet fullført (Antatt)
1. desember 2038
Datoer for studieregistrering
Først innsendt
10. juli 2026
Først innsendt som oppfylte QC-kriteriene
10. juli 2026
Først lagt ut (Faktiske)
16. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00095260
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .