Clinical trial · Observational
Tempus Open Link for Individual Voices in Innovative Analytics Registry: Platform Protocol for Multimodal Real-World Evidence in Cancer
TEMPUS ONCO-OLIVIA Registry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Pediatric Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia | ALIAS | 0.90 |
| Solid Tumor Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Substudy OLV002: Pediatric Acute Myeloid Leukemia (pAML)
- description
- Prospective, decentralized, participant/caregiver-mediated data registry for real-world evidence generation in pediatric AML. This is a minimal-risk, observational registry focused on pAML- intentional data collection (i.e., surveys/PROs), and associated evidence generation. Pediatric patients with confirmed AML diagnosis (eg, consented and authorized patients with completed laboratory test results and/or confirmed cancer diagnoses) in the United States. Pediatric subject's parent/legally authorized representative will consent for their participation and inclusion into the registry.
Primary outcomes (1)
- measure
- Completeness and Yield of Multi-Modal Real-World Data Capture
- timeFrame
- Through study completion, up to 5 years
- description
- Proportion of consented participants with successfully integrated and curated multimodal datasets (combining longitudinal electronic health record \[EHR\] data and genomic testing).
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available