CancerONCO-OLIVIANCT07756034
Tempus Open Link for Individual Voices in Innovative Analytics Registry: Platform Protocol for Multimodal Real-World Evidence in Cancer
An observational study of Cancer and Solid Tumor Cancer, run by Tempus AI at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cancer, Solid Tumor Cancer, Pediatric Acute Myeloid Leukemia
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Jul 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
- Receiving or have received care in the United States and/or U.S. Territories
Show all 11Show fewer
- 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
Who cannot join
- Not Applicable
- Substudy OLV002: Pediatric Acute Myeloid Leukemia (pAML):
- Suspected but unconfirmed acute myeloid leukemia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tempus AI
Chicago, Illinois, 60654
Mark Shapiro, 833-514-4187, support@oliviahealth.ai
Mark Shapiro
About this study
Official title: TEMPUS ONCO-OLIVIA Registry
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.
Read the detailed 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.
- Keywords
- Registry, Olivia, De-centralized
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Tempus AIThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tempus AI
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Blood Cancer United
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756034
- Sponsor's protocol ID
- TP-CA-011
- Acronym
- ONCO-OLIVIA
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be de-identified and aggregated.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEMPUS ONCO-OLIVIA Registry
- ClinicalTrials.gov ID
- NCT07756034
- Acronym / sponsor ID
- ONCO-OLIVIA / TP-CA-011
- Keywords
- Registry, Olivia, De-centralized
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tempus AIIndustry (pharma, biotech, devices)
- Collaborators
- Blood Cancer United
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- Not Applicable
- Suspected but unconfirmed acute myeloid leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completeness and Yield of Multi-Modal Real-World Data Capture
Time frame: Through study completion, up to 5 years
Proportion of consented participants with successfully integrated and curated multimodal datasets (combining longitudinal electronic health record [EHR] data and genomic testing).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. All data will be de-identified and aggregated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Solid Tumor Cancer, run by Tempus AI at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia Study Team (833-514-4187, support@oliviahealth.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completeness and Yield of Multi-Modal Real-World Data Capture (time frame: Through study completion, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.