Oncology, Solid Tumor, Adult
Conditions
Keywords
Molecular Profiling, Biomarker Analysis, Outcomes Database
Brief summary
This repository is a multi-center, outcomes study designed to retrospectively 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.
Detailed description
This repository is a multi-center, outcomes study designed to retrospectively 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. Patients who have had CMI testing prior to the initial IRB submission date of November 11, 2016 for the respective site would be eligible to have their treatment and treatment response data entered into the study Database. All entered data would be de-identified. The patient's CMI biomarker results and treatment response data will be coupled together in order to allow the investigation of research questions concerning biomarker status and treatment response.
Interventions
DIAGNOSTIC_TESTCaris Molecular Intelligence Profile
A comprehensive biomarker testing
Sponsors
Caris Science, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject' s age must be greater than or equal to 18 years and must have received CMI testing prior to the initial protocol IRB submission date of November 11, 2016.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data Gathering | 5 years per patient | Documentation of the frequency of specific clinical events in relation to diagnosis, treatments and outcomes provided |
Countries
United States
Outcome results
None listed