Recruiting

Observational Study

Sponsor:

Tempus AI

Code:

NCT07756034

Conditions

Cancer

Solid Tumor Cancer

Pediatric Acute Myeloid Leukemia

Hematologic Malignancies

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Cancer

Solid Tumor Cancer

Pediatric Acute Myeloid Leukemia

Hematologic Malignancies

Study ID

NCT07756034

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Jul, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Substudy OLV002: Pediatric Acute Myeloid Leukemia (pAML)

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 outcome measure

  • Completeness and Yield of Multi-Modal Real-World Data Capture [ Time Frame: Through study completion, up to 5 years ]

Central Contacts and Locations

Central contacts

Olivia Study Team

833-514-4187support@oliviahealth.ai

Locations

Tempus AI

Recruiting

Chicago, Illinois, United States, 60654

Contacts

Mark Shapiro

833-514-4187support@oliviahealth.ai

Principal Investigator:

Mark Shapiro

More Information

Sponsor

Tempus AI

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Registry
  • Olivia
  • De-centralized

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tempus AI on 2026-08-10.