๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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