Breast CancerNCT05179824
Tempus Priority Study: A Pan-tumor Observational Study
An observational study of Breast Cancer and Prostate Cancer, run by Tempus AI at 2 sites in United States.
Trial summary
Observational study that will be collecting clinical and molecular health information from cancer patients who have received comprehensive genomic profiling and meet the specific eligibility criteria outlined for each cohort with the goal of conducting research to advance cancer care and create a dataset that furthers… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Bladder Cancer
- What is being tested?
- Observation
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Oct 2020to 19 Oct 2030
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: This protocol targets a broad spectrum of cancer patients with comprehensive genomic profiling.
Who may be able to join
- Solid or hematologic malignancy.
- Willing and able to provide informed consent where required.
- Has received or will receive genomic profiling.
Who cannot join
- Individuals without the capacity to consent.
- Prisoners at the time of enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT Southwestern
Dallas, Texas, 75390
Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: Tempus Priority Study: An Observational Study of Patients Who Have Received Comprehensive Genomic Profiling
Observational study that will be collecting clinical and molecular health information from cancer patients who have received comprehensive genomic profiling and meet the specific eligibility criteria outlined for each cohort with the goal of conducting research to advance cancer care and create a dataset that furthers cancer research.
Read the detailed description
The Study will collect combined clinical and molecular health information for cancer patients in the United States from multiple academic medical centers and community oncology practices. Participants who agree to join the Study will have their molecular profiling results, associated clinical health information, and longitudinal outcomes health information collected by the participating Institution for submission to Tempus. The specific goal of the Study is to create an outcomes-based dataset for future research to improve cancer treatment.
- Conditions
- Breast Cancer, Prostate Cancer, Bladder Cancer, Lung Cancer, Brain Cancer, Pancreatic Cancer
- Being tested
- Observation
- Keywords
- Cancer, Oncology, Observational, Genomic Profiling, Precision Medicine
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Urinary Bladder Neoplasms, Lung Neoplasms, Brain Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standard of Care (SOC) CGP | This group will facilitate collection of paired clinical and molecular data done as part of the standard of care or routine clinical care across a variety of institutions. The goal of Group 1 is to capture a broad range of participants to better understand longitudinal outcomes across institutions and standards of care. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Create robust data set of health information
To create a robust data set of health information about cancer patients who receive comprehensive genomic profiling in order to facilitate future novel precision medicine research
Measured: Up to 10 years
Secondary outcomes (2)
Document clinical events for patients who have had comprehensive genomic profiling
To document specific clinical events in relation to diagnosis, treatment, and outcomes for patients who have had comprehensive genomic profiling
Measured: Up to 10 years
Evaluate longitudinal paired tissue and cell free molecular testing
To evaluate the feasibility of longitudinal paired tissue and cell free molecular testing of participants with specific types of cancer, mutations, or therapies
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start19 Oct 2020
- Primary completion19 Oct 2026 (estimated)
- Study completion19 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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)
Sponsor and investigators
- Lead sponsor
- Tempus AI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristiyana Kaneva, MD, MS, MBA, Principal investigator, Tempus AI, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179824
- Sponsor's protocol ID
- TP-CA-001
- Status last verified
- May 2025
- First submitted
- 16 Dec 2021
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zehir A, Benayed R, Shah RH, Syed A, Middha S, Kim HR, Srinivasan P, Gao J, Chakravarty D, Devlin SM, Hellmann MD, Barron DA, Schram AM, Hameed M, Dogan S, Ross DS, Hechtman JF, DeLair DF, Yao J, Mandelker DL, Cheng DT, Chandramohan R, Mohanty AS, Ptashkin RN, Jayakumaran G, Prasad M, Syed MH, Rema AB, Liu ZY, Nafa K, Borsu L, Sadowska J, Casanova J, Bacares R, Kiecka IJ, Razumova A, Son JB, Stewart L, Baldi T, Mullaney KA, Al-Ahmadie H, Vakiani E, Abeshouse AA, Penson AV, Jonsson P, Camacho N, Chang MT, Won HH, Gross BE, Kundra R, Heins ZJ, Chen HW, Phillips S, Zhang H, Wang J, Ochoa A, Wills J, Eubank M, Thomas SB, Gardos SM, Reales DN, Galle J, Durany R, Cambria R, Abida W, Cercek A, Feldman DR, Gounder MM, Hakimi AA, Harding JJ, Iyer G, Janjigian YY, Jordan EJ, Kelly CM, Lowery MA, Morris LGT, Omuro AM, Raj N, Razavi P, Shoushtari AN, Shukla N, Soumerai TE, Varghese AM, Yaeger R, Coleman J, Bochner B, Riely GJ, Saltz LB, Scher HI, Sabbatini PJ, Robson ME, Klimstra DS, Taylor BS, Baselga J, Schultz N, Hyman DM, Arcila ME, Solit DB, Ladanyi M, Berger MF. Mutational landscape of metastatic cancer revealed from prospective clinical sequencing of 10,000 patients. Nat Med. 2017 Jun;23(6):703-713. doi: 10.1038/nm.4333. Epub 2017 May 8.
PubMed 28481359Daoud A, Chu QS. Targeting Novel but Less Common Driver Mutations and Chromosomal Translocations in Advanced Non-Small Cell Lung Cancer. Front Oncol. 2017 Sep 29;7:222. doi: 10.3389/fonc.2017.00222. eCollection 2017.
PubMed 29034207Ersek JL, Black LJ, Thompson MA, Kim ES. Implementing Precision Medicine Programs and Clinical Trials in the Community-Based Oncology Practice: Barriers and Best Practices. Am Soc Clin Oncol Educ Book. 2018 May 23;38:188-196. doi: 10.1200/EDBK_200633.
PubMed 30231363Griffith SD, Tucker M, Bowser B, Calkins G, Chang CJ, Guardino E, Khozin S, Kraut J, You P, Schrag D, Miksad RA. Generating Real-World Tumor Burden Endpoints from Electronic Health Record Data: Comparison of RECIST, Radiology-Anchored, and Clinician-Anchored Approaches for Abstracting Real-World Progression in Non-Small Cell Lung Cancer. Adv Ther. 2019 Aug;36(8):2122-2136. doi: 10.1007/s12325-019-00970-1. Epub 2019 May 28.
PubMed 31140124
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tempus Priority Study: An Observational Study of Patients Who Have Received Comprehensive Genomic Profiling
- ClinicalTrials.gov ID
- NCT05179824
- Acronym / sponsor ID
- TP-CA-001
- Conditions
- Breast Cancer, Prostate Cancer, Bladder Cancer, Lung Cancer, Brain Cancer, Pancreatic Cancer
- Keywords
- Cancer, Oncology, Observational, Genomic Profiling, Precision Medicine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tempus AIIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 19 Oct 2026 (estimated)
- Study completion
- 19 Oct 2030 (estimated)
- First posted
- 5 Jan 2022 (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.
Observational study that will be collecting clinical and molecular health information from cancer patients who have received comprehensive genomic profiling and meet the specific eligibility criteria outlined for each cohort with the goal of conducting research to advance cancer care and create a dataset that furthers cancer research.
Detailed description
The Study will collect combined clinical and molecular health information for cancer patients in the United States from multiple academic medical centers and community oncology practices. Participants who agree to join the Study will have their molecular profiling results, associated clinical health information, and longitudinal outcomes health information collected by the participating Institution for submission to Tempus. The specific goal of the Study is to create an outcomes-based dataset for future research to improve cancer treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: Standard of Care (SOC) CGP | – | Other: ObservationThis group will facilitate collection of paired clinical and molecular data done as part of the standard of care or routine clinical care across a variety of institutions. The goal of Group 1 is to capture a broad range of participants to better understand longitudinal outcomes across institutions and standards of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This protocol targets a broad spectrum of cancer patients with comprehensive genomic profiling.
Key inclusion criteria (3 listed)
- Solid or hematologic malignancy.
- Willing and able to provide informed consent where required.
- Has received or will receive genomic profiling.
Key exclusion criteria (2 listed)
- Individuals without the capacity to consent.
- Prisoners at the time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationNo Intervention | Other | Group 1: Standard of Care (SOC) CGP |
Primary outcome
Create robust data set of health information
Time frame: Up to 10 years
To create a robust data set of health information about cancer patients who receive comprehensive genomic profiling in order to facilitate future novel precision medicine research
2 secondary outcomes
Document clinical events for patients who have had comprehensive genomic profiling
Time frame: Up to 10 years
Evaluate longitudinal paired tissue and cell free molecular testing
Time frame: Up to 10 years
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 6 May 2025.
- Background: PubMed 28481359Zehir A, Benayed R, Shah RH, Syed A, Middha S, Kim HR, Srinivasan P, Gao J, Chakravarty D, Devlin SM, Hellmann MD, Barron DA, Schram AM, Hameed M, Dogan S, Ross DS, Hechtman JF, DeLair DF, Yao J, Mandelker DL, Cheng DT, Chandramohan R, Mohanty AS, Ptashkin RN, Jayakumaran G, Prasad M, Syed MH, Rema AB, Liu ZY, Nafa K, Borsu L, Sadowska J, Casanova J, Bacares R, Kiecka IJ, Razumova A, Son JB, Stewart L, Baldi T, Mullaney KA, Al-Ahmadie H, Vakiani E, Abeshouse AA, Penson AV, Jonsson P, Camacho N, Chang MT, Won HH, Gross BE, Kundra R, Heins ZJ, Chen HW, Phillips S, Zhang H, Wang J, Ochoa A, Wills J, Eubank M, Thomas SB, Gardos SM, Reales DN, Galle J, Durany R, Cambria R, Abida W, Cercek A, Feldman DR, Gounder MM, Hakimi AA, Harding JJ, Iyer G, Janjigian YY, Jordan EJ, Kelly CM, Lowery MA, Morris LGT, Omuro AM, Raj N, Razavi P, Shoushtari AN, Shukla N, Soumerai TE, Varghese AM, Yaeger R, Coleman J, Bochner B, Riely GJ, Saltz LB, Scher HI, Sabbatini PJ, Robson ME, Klimstra DS, Taylor BS, Baselga J, Schultz N, Hyman DM, Arcila ME, Solit DB, Ladanyi M, Berger MF. Mutational landscape of metastatic cancer revealed from prospective clinical sequencing of 10,000 patients. Nat Med. 2017 Jun;23(6):703-713. doi: 10.1038/nm.4333. Epub 2017 May 8.
- Background: PubMed 29034207Daoud A, Chu QS. Targeting Novel but Less Common Driver Mutations and Chromosomal Translocations in Advanced Non-Small Cell Lung Cancer. Front Oncol. 2017 Sep 29;7:222. doi: 10.3389/fonc.2017.00222. eCollection 2017.
- Background: PubMed 30231363Ersek JL, Black LJ, Thompson MA, Kim ES. Implementing Precision Medicine Programs and Clinical Trials in the Community-Based Oncology Practice: Barriers and Best Practices. Am Soc Clin Oncol Educ Book. 2018 May 23;38:188-196. doi: 10.1200/EDBK_200633.
- Background: PubMed 31140124Griffith SD, Tucker M, Bowser B, Calkins G, Chang CJ, Guardino E, Khozin S, Kraut J, You P, Schrag D, Miksad RA. Generating Real-World Tumor Burden Endpoints from Electronic Health Record Data: Comparison of RECIST, Radiology-Anchored, and Clinician-Anchored Approaches for Abstracting Real-World Progression in Non-Small Cell Lung Cancer. Adv Ther. 2019 Aug;36(8):2122-2136. doi: 10.1007/s12325-019-00970-1. Epub 2019 May 28.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
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. This study is not recruiting at the moment.
Kristiyana Kaneva, MD, MS, MBA principal investigator
Tempus AI, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Prostate Cancer, run by Tempus AI at 2 sites 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create robust data set of health information (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05179824, which also lists 4 linked publications.
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 6 May 2025.