POA Prospective Repository

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository

Conditions
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Solid Tumor, Adult, Oncology

Intervention / Treatment
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* Diagnostic Test: Caris MI Profiling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject's age must be greater than or equal to 18 years and must have received CMI testing Exclusion Criteria: Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients shall not be approached for participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MI Profiling<br>Subjects must have undergone Caris MI Profiling in order to be eligible for the study. No required intervention is dictated by the protocol. | Diagnostic Test: Caris MI Profiling<br>* Customized comprehensive biomarker testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | within 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Molecular Profiling, Biomarker Analysis, Next Generation Sequencing