NCT03324841

POA Prospective Repository

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Caris Science, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

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.

Conditions

• Solid Tumor, Adult
• Oncology

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Caris MI Profiling	Customized comprehensive biomarker testing

Timeline

• Start date: 2017-06-07
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2017-10-30
• Last updated: 2020-01-27

Locations

11 sites across 1 country: United States