跳至主要内容
临床试验/NCT07756034
NCT07756034招募中不适用

TEMPUS ONCO-OLIVIA Registry

Tempus AI1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Tempus AI
入组人数
1,000
试验地点
1
主要终点
Completeness and Yield of Multi-Modal Real-World Data Capture

研究概览

简要总结

This study entails enrolling participants that have been diagnosed with cancer to Olivia, a commercially available AI-enabled personal health platform developed by Tempus.

Olivia will serve as the primary interface for eConsent and enrollment into the registry. The platform will also help create a retrospective and prospective registry by working with over 1,000 healthcare systems to combine electronic health records (EHR) and Patient Reported Outcomes (PROs) in a single spot.

There may be sub-studies as an add-on to this parent protocol. The sub-studies will address specific goals of the targeted research activities and will usually include additional information specific to each research study.

详细描述

Olivia will capture data through continuous data accrual, multimodal integration, and longitudinal depth. Data may be collected from areas including, but not limited to, clinical/EHR, pathology/genomics, imaging, PROs, or linkage.

Primary pathway: Olivia-enabled remote eConsent/authorization under HIPAA Right of Access and TEFCA Individual Access Services (IAS) to retrieve medical records. Data are curated into de-identified/coded, auditable datasets for research and potential secondary research and/or regulatory uses. Retrospective capture reaches back to diagnosis or earlier when available. Participation does not affect clinical care or access to care, and no investigational treatments or research-mandated procedures are administered.

Sub-studies will routinely include supplemental information specific to each research project, including but not limited to the following: purpose, objective(s), background, design, population(s) of interest (e.g., inclusion or exclusion criteria), analytic method(s), storage and archival considerations, etc.

Depending on the nature of the research partnership, sub-studies may designate a co-Principal Investigator and/or co-Sponsor to support the sub-study-specific research effort. In such cases, the respective roles, responsibilities, and regulatory obligations of each party will be documented in the sub-study protocol and associated agreements, while Tempus retains overall sponsorship and governance of the Olivia platform.

The Olivia platform has its own standard Terms of Use; however, for the purposes of this research, the Informed Consent Form (ICF) serves as the governing document. In the event of any conflict between the platform's standard terms and the ICF regarding research-specific rights, data protections, or liability, the terms of the ICF will prevail.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • ONCO-OLIVIA Registry:
  • Inclusion Criteria:
  • Adults or children (all ages) with a pathologically confirmed diagnosis of cancer (solid tumor or hematologic malignancy) documented in the medical record; disease-specific cohorts may further define subtypes (e.g., stage, biomarker)
  • Receiving care in the United States and/or U.S. Territories
  • Participant (and/or legally authorized representative) is able and willing to provide electronic informed consent/permission and authorization via Olivia; with re-consent at age of eighteen if applicable
  • Willing to authorize medical record retrieval under HIPAA Right of Access and/or TEFCA IAS
  • Access to a smartphone, tablet, or web-enabled device for remote participation (directly or via caregiver) for eConsent and optional surveys

排除标准

  • Not Applicable
  • Substudy OLV002: Pediatric Acute Myeloid Leukemia (pAML):
  • Inclusion Criteria:
  • Receiving or have received care in the United States and/or U.S. Territories
  • Participant (and/or legally authorized representative) is able and willing to provide electronic informed consent/permission and authorization via the platform; with re-consent at age of eighteen if applicable
  • Legally authorized representative of participant who is deceased is able and willing to provide electronic informed consent/permission and authorization via the platform
  • Willing to authorize medical record retrieval under HIPAA Right of Access and/or TEFCA IAS
  • Access to a smartphone, tablet, or web-enabled device for remote participation (directly or via caregiver) for eConsent and cohort dependent PROs/surveys
  • Pediatric patients with a confirmed diagnosis of Acute Myeloid Leukemia (AML) including the following AML subtypes per WHO/ICC classification: AML with core-binding factor rearrangements (AML-CBF), AML with inv(16) (AML-NV16), acute promyelocytic leukemia (APL), AML with KMT2A rearrangement (AML-KMT2A), AML with mutated NPM1 (AML-NPM1), AML with bZIP CEBPA mutations (AML-bZIP), AML with MECOM rearrangement
  • Exclusion Criteria:
  • - Suspected but unconfirmed acute myeloid leukemia

结局指标

主要结局

Completeness and Yield of Multi-Modal Real-World Data Capture

时间窗: Through study completion, up to 5 years

Proportion of consented participants with successfully integrated and curated multimodal datasets (combining longitudinal electronic health record \[EHR\] data and genomic testing).

次要结局

未报告次要终点

研究者

发起方
Tempus AI
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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