POA Retrospective Repository

• Conditions: Oncology; Solid Tumor, Adult
• Interventions: Diagnostic Test: Caris Molecular Intelligence Profile

• Registration Number: NCT03326479
• Lead Sponsor: Caris Science, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2016-11-30
• Status Verified: 2017-10
• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-26
• Last Update Submitted: 2017-10-26
• Study First Posted: 2017-10-31
• Last Update Posted: 2017-10-31
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective	Caris Molecular Intelligence Profile	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.

Primary Outcome Measures

Name	Time	Method
Data Gathering	5 years per patient	Documentation of the frequency of specific clinical events in relation to diagnosis, treatments and outcomes provided

Trial Locations

Locations (3)

The University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

Nebraska Cancer Specialists; 🇺🇸 Omaha, Nebraska, United States

Highlands Oncology Group; 🇺🇸 Fayetteville, Arkansas, United States