POA Prospective Repository

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Oncology; Solid Tumor, Adult
• Intervention / Treatment: Diagnostic test: Caris MI Profiling

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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth
    • Tucson, Arizona, United States, 85719
      • University of Arizona
  • California
    • Irvine, California, United States, 92612
      • St. Joseph Heritage Healthcare
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Health Research Institute, Inc.
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando Cancer Institute
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Nebraska Cancer Specialists
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Health, LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • The Institute for Cancer Research dba The Research Institute of Fox Chase Cancer Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic
  • Texas
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who received Caris MI Profiling at one of the Precision Oncology Alliance (POA) sites

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Caris MI Profiling; Customized comprehensive biomarker testing

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Caris Science, Inc.
• Investigators: Study Director: W. Michael Korn, MD, Caris Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2017
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Molecular Profiling; Biomarker Analysis; Next Generation Sequencing
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: COE-001-0815

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No