Overview
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.
Description
Olivia will capture data through continuous data accrual, multimodal integration, and longitudinal depth. Data may be collected from areas including, but not limited to, clinical/EHR, pathology/genomics, imaging, PROs, or linkage.
Primary pathway: Olivia-enabled remote eConsent/authorization under HIPAA Right of Access and TEFCA Individual Access Services (IAS) to retrieve medical records. Data are curated into de-identified/coded, auditable datasets for research and potential secondary research and/or regulatory uses. Retrospective capture reaches back to diagnosis or earlier when available. Participation does not affect clinical care or access to care, and no investigational treatments or research-mandated procedures are administered.
Sub-studies will routinely include supplemental information specific to each research project, including but not limited to the following: purpose, objective(s), background, design, population(s) of interest (e.g., inclusion or exclusion criteria), analytic method(s), storage and archival considerations, etc.
Depending on the nature of the research partnership, sub-studies may designate a co-Principal Investigator and/or co-Sponsor to support the sub-study-specific research effort. In such cases, the respective roles, responsibilities, and regulatory obligations of each party will be documented in the sub-study protocol and associated agreements, while Tempus retains overall sponsorship and governance of the Olivia platform.
The Olivia platform has its own standard Terms of Use; however, for the purposes of this research, the Informed Consent Form (ICF) serves as the governing document. In the event of any conflict between the platform's standard terms and the ICF regarding research-specific rights, data protections, or liability, the terms of the ICF will prevail.
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
