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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTempus AI

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Not Applicable

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Substudy OLV002: Pediatric Acute Myeloid Leukemia (pAML)

Trial outcomes

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).

Time frame
Through study completion, up to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tempus AI

Lead sponsor

Blood Cancer United

Collaborator