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
調査の概要
詳細な説明
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
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Halle Hall
- 電話番号：+1 (646) 832-2265
- メール：halle.hall@ataraxis.ai
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
A large-scale, multi-site registry linking Ataraxis test results with short- and long-term clinical outcomes
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Performance and clinical utility of Ataraxis tests across diverse patient populations
時間枠：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
時間枠：10 years
|
Leverage the shared registry infrastructure to support downstream independent research by contributing site-investigators.
|
10 years
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Jan Witowski, MD, PhD、Ataraxis AI
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。