POA Prospective Repository

NCT03324841 | Unknown

• 1 other identifier: COE-001-0815
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Solid Tumor, Adult; Oncology

Keywords

Molecular Profiling; Biomarker Analysis; Next Generation Sequencing

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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

Interventions

Caris MI Profiling DIAGNOSTIC_TEST

Customized comprehensive biomarker testing

MI Profiling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Subject's age must be greater than or equal to 18 years and must have received CMI testing

You may not qualify if:

• Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients shall not be approached for participation.

Sponsors & Collaborators

• Caris Science, Inc.: lead

Study Sites (11)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

University of Arizona

Tucson, Arizona, 85719, United States

Location

St. Joseph Heritage Healthcare

Irvine, California, 92612, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

MedStar Health Research Institute, Inc.

Washington D.C., District of Columbia, 20007, United States

Location

AdventHealth Orlando Cancer Institute

Orlando, Florida, 32803, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

University of Cincinnati Health, LLC

Cincinnati, Ohio, 45219, United States

Location

The Institute for Cancer Research dba The Research Institute of Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

The West Clinic

Germantown, Tennessee, 38138, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• W. Michael Korn, MD

  Caris Life Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 30, 2017
• Study Start: June 7, 2017
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (11)