POA Prospective Repository

Solid Tumor, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03324841
• Other study ID #: COE-001-0815
• Status: Enrolling by invitation
• Start date: June 7, 2017
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2020
• Source: Caris Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Oncology
• Solid Tumor, Adult

Intervention

Diagnostic Test:
• Caris MI Profiling
Customized comprehensive biomarker testing

Locations

Country	Name	City	State
United States	University of Cincinnati Health, LLC	Cincinnati	Ohio
United States	The West Clinic	Germantown	Tennessee
United States	St. Joseph Heritage Healthcare	Irvine	California
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	AdventHealth Orlando Cancer Institute	Orlando	Florida
United States	The Institute for Cancer Research dba The Research Institute of Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	John Wayne Cancer Institute	Santa Monica	California
United States	HonorHealth	Scottsdale	Arizona
United States	University of Arizona	Tucson	Arizona
United States	MedStar Health Research Institute, Inc.	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Caris Science, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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