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This repository is a multi-center, outcomes study designed to collect data on the demographics, presentation, diagnosis, treatment, cost of associated care, quality of life, and outcomes of subjects utilizing Caris Molecular Intelligence® (CMI) Services for the treatment of cancer.
This repository is a multi-center, outcomes study designed to collect data on the demographics, presentation, diagnosis, treatment, cost of associated care, quality of life, and outcomes of subjects utilizing Caris Molecular Intelligence® (CMI) Services for the treatment of cancer. Prior to enrolling a subject, the subject's physician will have made the independent decision whether or not to utilize the drug associations provided by CMI and made clinical treatment choices as appropriate. Thus, data captured and reported provides a "real world" perspective on diagnosis, treatment, cost, and outcomes.
Prospective data will be obtained only from consented patients or patients who have died or have been lost to follow-up. Lost to follow-up is defined as a subject who has not returned for continued care or evaluation (e.g., disability, relocation or unresponsiveness). Site coordinators are required attempt to contact the subject 3 times before deeming them lost to follow up. Data collection and the protection of privacy are discussed in the Methods section below.
In addition to treatment and response data, initial diagnosis and staging results will be recorded as well as any recurrence information. As the investigators are capturing the subject's cancer treatment as a whole, results from pertinent cancer-related tests performed by outside entities for eligible subjects will need to be collected by the site coordinator and maintained at the site accordingly for reporting and monitoring purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MI Profiling | Subjects must have undergone Caris MI Profiling in order to be eligible for the study. No required intervention is dictated by the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caris MI Profiling | Diagnostic Test | Customized comprehensive biomarker testing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effecting Change | Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. | within 5 years |
| Performing retrospective research | Performing retrospective research including clinical presentation, treatment and outcomes. This eligible cohort includes select subjects who have already undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. | within 5 years |
| Evaluate the frequency of specific clinical events | Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. | within 5 years |
| Provide information access that is vital to research collaborators | Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. | within 5 years |
| Cultivate a repository for assay development | Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who received Caris MI Profiling at one of the Precision Oncology Alliance (POA) sites
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| Name | Affiliation | Role |
|---|---|---|
| W. Michael Korn, MD | Caris Life Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Scottsdale | Arizona | 85258 | United States | ||
| University of Arizona |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| within 5 years |
| Tucson |
| Arizona |
| 85719 |
| United States |
| St. Joseph Heritage Healthcare | Irvine | California | 92612 | United States |
| John Wayne Cancer Institute | Santa Monica | California | 90404 | United States |
| MedStar Health Research Institute, Inc. | Washington D.C. | District of Columbia | 20007 | United States |
| AdventHealth Orlando Cancer Institute | Orlando | Florida | 32803 | United States |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
| University of Cincinnati Health, LLC | Cincinnati | Ohio | 45219 | United States |
| The Institute for Cancer Research dba The Research Institute of Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| The West Clinic | Germantown | Tennessee | 38138 | United States |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |