Recruiting
Observational
Tempus Open Link for Individual Voices in Innovative Analytics Registry: Platform Protocol for Multimodal Real-World Evidence in Cancer
Condition(s) studied
CancerSolid Tumor CancerPediatric Acute Myeloid LeukemiaHematologic Malignancies
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Completeness and Yield of Multi-Modal Real-World Data Capture — 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).
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Tempus AI |
Chicago |
Illinois |
Recruiting |
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