POA Retrospective Repository

Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Oncology; Solid Tumor, Adult
• Intervention / Treatment: Diagnostic test: Caris Molecular Intelligence Profile

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.

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

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Nebraska Cancer Specialists
  • 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject's who have had CMI testing prior to 11/11/2016 at one of the participating POA sites.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective; Subject who have previously had MI Profiling performed prior to 11/11/2016 are eligible for this study. No drug intervention is required for this study.	Diagnostic test: Caris Molecular Intelligence Profile; A comprehensive biomarker testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data Gathering	Documentation of the frequency of specific clinical events in relation to diagnosis, treatments and outcomes provided	5 years per patient

Collaborators and Investigators

• Sponsor: Caris Science, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2016
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Molecular Profiling; Biomarker Analysis; Outcomes Database
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: COE-002-1116

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No