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

NCT07756034 | Recruiting

• 1 other identifier: TP-CA-011
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

Registry; Olivia; De-centralized

Outcome Measures

Primary Outcomes (1)

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

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

  Through study completion, up to 5 years

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All ages (adults and pediatrics), all indications (including solid tumors and hematologic malignancies, rare and genetic diseases, patients with suspected cancer or rare diseases, and healthy patients who have or may receive Tempus testing) and are receiving clinical care in the United States and/or U.S. Territories. Pathologically confirmed cancer diagnoses required for cohort-level analyses; biomarker-specific cohorts may be defined via the sub-study.

You may qualify if:

• 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

You may not qualify if:

• Not Applicable
• Substudy OLV002: Pediatric Acute Myeloid Leukemia (pAML):
• 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
• \- Suspected but unconfirmed acute myeloid leukemia

Sponsors & Collaborators

• Tempus AI: lead
• Blood Cancer United: collaborator

Study Sites (1)

Tempus AI

Chicago, Illinois, 60654, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Olivia Study Team

CONTACT

833-514-4187; support@oliviahealth.ai

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)