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Tempus Priority Study: A Pan-tumor Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05179824
Recruitment Status : Recruiting
First Posted : January 5, 2022
Last Update Posted : May 16, 2022
Sponsor:
Information provided by (Responsible Party):
Tempus Labs

Brief 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.

Condition or disease Intervention/treatment
Breast Cancer Prostate Cancer Bladder Cancer Lung Cancer Brain Cancer Pancreatic Cancer Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Cancer of Liver Cancer of Colon Cancer of Head and Neck Cancer of Stomach Cancer of Gastrointestinal Tract Cancer of Rectum Cancer of Esophagus Cancer of Skin Cancer of Cervix Cancer of Kidney Cancer of Larynx Cancer of Endometrium Cancer of the Bile Duct Cancer of Vulva Cancer of Bone and Connective Tissue Leukemia Lymphoma Spinal Cord Cancer Other: Observation

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Tempus Priority Study: An Observational Study of Patients Who Have Received Comprehensive Genomic Profiling
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : October 19, 2026
Estimated Study Completion Date : October 19, 2030


Group/Cohort Intervention/treatment
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.
Other: Observation
No Intervention

Group 2: Disease or Profile Specific Cohorts

Group 2 will consist of specific cohorts that will facilitate collection of paired clinical and molecular data done outside of the standard of care, longitudinal CGP, or narrowly defined cohorts based on mutations or treatment settings. The goal of Group 2 is to capture specific participants in specific cohorts to better understand longitudinal outcomes across institutions and standards of care.

Protocol contains complete eligibility criteria.

Other: Observation
No Intervention




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Document clinical events for patients who have had comprehensive genomic profiling [ Time Frame: Up to 10 years ]
    To document specific clinical events in relation to diagnosis, treatment, and outcomes for patients who have had comprehensive genomic profiling

  2. Evaluate longitudinal paired tissue and cell free molecular testing [ Time Frame: Up to 10 years ]
    To evaluate the feasibility of longitudinal paired tissue and cell free molecular testing of participants with specific types of cancer, mutations, or therapies


Other Outcome Measures:
  1. Support prospective and retrospective research studies [ Time Frame: Up to 10 years ]
    To support prospective and retrospective research studies on participants with specific cancer types

  2. Describe real world treatment outcomes [ Time Frame: Up to 10 years ]
    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)

  3. Review medical information for standard of care decisions and health outcomes [ Time Frame: Up to 10 years ]
    To review medical information for standard of care decisions in the future and general health outcomes


Biospecimen Retention:   Samples With DNA
Archival tissue will be collected.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This protocol targets a broad spectrum of cancer patients with comprehensive genomic profiling.
Criteria

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.

I/E criteria are specific for each cohort of Group 2 and available in the full protocol.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05179824


Contacts
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Contact: PRIORITY Study (833) 514-4187 prioritystudy@tempus.com

Locations
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United States, Louisiana
Pontchartrain Cancer Center Recruiting
Covington, Louisiana, United States, 70433
Contact: Jessica Faucheaux    985-888-1523    jfaucheaux@pcclouisiana.com   
United States, Missouri
Central Care Cancer Center Recruiting
Bolivar, Missouri, United States, 65613
Contact: Michelle Cahow    417-326-7200 ext 209    Michelle.Cahow@cccancer.com   
United States, New Jersey
New Jersey Cancer Center and Blood Disorders, New Jersey Cancer Care Recruiting
Belleville, New Jersey, United States, 07109
Contact: Michael Johnstone    973-751-8880 ext 272    trials@njcancercare.com   
United States, New York
Perlmutter Cancer Center, NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Xiaohong Jing    734-945-0665    Xiaohong.Jing@nyulangone.org   
United States, Ohio
TriHealth Cancer Institute- Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Wayne Thompson    513-865-5020    wayne_thompson@trihealth.com   
OhioHealth Recruiting
Columbus, Ohio, United States, 43214
Contact: Kevin Miller    614-788-3886    Kevin.miller@ohiohealth.com   
United States, Pennsylvania
Cancer Care Associates of York Recruiting
York, Pennsylvania, United States, 17403
Contact: Jennifer Stough    717-741-9229    jstough@cancercareyork.com   
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Merin Thomas    713-798-7291    merint@bcm.edu   
Sponsors and Collaborators
Tempus Labs
Investigators
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Principal Investigator: Kenneth Carson, MD, PhD Tempus Labs, Inc.
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. Erratum in: Nat Med. 2017 Aug 4;23 (8):1004.

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Responsible Party: Tempus Labs
ClinicalTrials.gov Identifier: NCT05179824    
Other Study ID Numbers: TP-CA-001
First Posted: January 5, 2022    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tempus Labs:
Cancer
Oncology
Observational
Genomic Profiling
Precision Medicine
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Brain Neoplasms
Head and Neck Neoplasms
Esophageal Neoplasms
Colonic Neoplasms
Stomach Neoplasms
Liver Neoplasms
Rectal Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Skin Neoplasms
Gastrointestinal Neoplasms
Bile Duct Neoplasms
Laryngeal Neoplasms
Bone Neoplasms
Vulvar Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urologic Neoplasms
Urologic Diseases
Fallopian Tube Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms