Tempus Priority Study: A Pan-tumor Observational Study

Breast Cancer Clinical Trial

Official title:

Tempus Priority Study: An Observational Study of Patients Who Have Received Comprehensive Genomic Profiling

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179824
• Other study ID #: TP-CA-001
• Status: Recruiting
• Start date: October 19, 2020
• Est. completion date: October 19, 2030

Study information

• Verified date: April 2024
• Source: Tempus AI
• Contact: PRIORITY Study
• Phone: (833) 514-4187
• Email: prioritystudy[@]tempus.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 cancer research.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 19, 2030
• Est. primary completion date: October 19, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Solid or hematologic malignancy.

2. Willing and able to provide informed consent where required.

3. Has received or will receive genomic profiling.

Exclusion Criteria:

1. Individuals without the capacity to consent.

2. Prisoners at the time of enrollment.

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Bladder Cancer
• Bone Neoplasms
• Brain Cancer
• Brain Neoplasms
• Breast Cancer
• Cancer of Cervix
• Cancer of Colon
• Cancer of Endometrium
• Cancer of Esophagus
• Cancer of Gastrointestinal Tract
• Cancer of Head and Neck
• Cancer of Kidney
• Cancer of Larynx
• Cancer of Liver
• Cancer of Rectum
• Cancer of Skin
• Cancer of Stomach
• Cancer of the Bile Duct
• Carcinoma, Renal Cell
• Colonic Neoplasms
• Endometrial Neoplasms
• Esophageal Neoplasms
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Gastrointestinal Neoplasms
• Head and Neck Neoplasms
• Kidney Neoplasms
• Laryngeal Neoplasms
• Leukemia
• Liver Neoplasms
• Lung Cancer
• Lymphoma
• Ovarian Cancer
• Pancreatic Cancer
• Peritoneal Cancer
• Prostate Cancer
• Rectal Neoplasms
• Skin Neoplasms
• Spinal Cord Cancer
• Stomach Neoplasms
• Uterine Cervical Neoplasms
• Vulvar Neoplasms

Intervention

Other:
• Observation
No Intervention

Locations

Country	Name	City	State
United States	New Jersey Cancer Center and Blood Disorders, New Jersey Cancer Care	Belleville	New Jersey
United States	Central Care Cancer Center	Bolivar	Missouri
United States	TriHealth Cancer Institute- Good Samaritan Hospital	Cincinnati	Ohio
United States	OhioHealth	Columbus	Ohio
United States	Pontchartrain Cancer Center	Covington	Louisiana
United States	UT Southwestern	Dallas	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Community Health	Indianapolis	Indiana
United States	Providence Medical Foundation	Napa	California
United States	Perlmutter Cancer Center, NYU Langone Health	New York	New York
United States	Oklahama Cancer Specialists and Research Institute	Tulsa	Oklahoma
United States	Cancer Care Associates of York	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Tempus AI

Country where clinical trial is conducted

United States, 

References & Publications (4)

Daoud 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. — View Citation

Ersek 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. — View Citation

Griffith 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. — View Citation

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. Erratum In: Nat Med. 2017 Aug 4;23 (8):1004. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Support prospective and retrospective research studies	To support prospective and retrospective research studies on participants with specific cancer types	Up to 10 years
Other	Describe real world treatment outcomes	To describe real world treatment outcomes (such as real-world response, real world duration of response, real world progression free survival, real world time to next treatment, real world time to treatment discontinuation, and overall survival)	Up to 10 years
Other	Review medical information for standard of care decisions and health outcomes	To review medical information for standard of care decisions in the future and general health outcomes	Up to 10 years
Primary	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	Up to 10 years
Secondary	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	Up to 10 years
Secondary	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	Up to 10 years