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RECRUITING

NCT07756034

Tempus Open Link for Individual Voices in Innovative Analytics Registry: Platform Protocol for Multimodal Real-World Evidence in Cancer

Sponsor: Tempus AI

View on ClinicalTrials.gov

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.

Official title: TEMPUS ONCO-OLIVIA Registry

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-08

Completion Date

2031-07

Last Updated

2026-08-10

Healthy Volunteers

Yes

Conditions

Cancer Solid Tumor Cancer Pediatric Acute Myeloid Leukemia Hematologic Malignancies

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

Locations (1)

Tempus AI

Chicago, Illinois, United States