## Protocol Section
### Identification Module
**NCT ID:** NCT03326479

**Brief Title:** POA Retrospective Repository

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

#### Organization Study ID Info
**ID:** COE-002-1116
#### Organization
**Class:** INDUSTRY
**Full Name:** Caris Science, Inc.
### Status Module
#### Completion Date
**Date:** 2023-01-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ENROLLING_BY_INVITATION
#### Last Update Post Date
**Date:** 2017-10-31

**Type:** ACTUAL

**Last Update Submit Date:** 2017-10-26

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2023-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-11-30

**Type:** ACTUAL

**Status Verified Date:** 2017-10

#### Study First Post Date
**Date:** 2017-10-31
**Type:** ACTUAL
**Study First Submit Date:** 2017-10-19
**Study First Submit QC Date:** 2017-10-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Caris Science, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Oncology

- Solid Tumor, Adult

**Keywords:**

- Molecular Profiling

- Biomarker Analysis

- Outcomes Database

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 10000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: Caris Molecular Intelligence Profile

**Label:** Retrospective

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Retrospective

**Description:** A comprehensive biomarker testing

**Name:** Caris Molecular Intelligence Profile

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Documentation of the frequency of specific clinical events in relation to diagnosis, treatments and outcomes provided

**Measure:** Data Gathering

**Time Frame:** 5 years per patient

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Fayetteville

**Country:** United States

**Facility:** Highlands Oncology Group

**State:** Arkansas

**Zip:** 72703

**Location 2:**

**City:** Omaha

**Country:** United States

**Facility:** Nebraska Cancer Specialists

**State:** Nebraska

**Zip:** 68130

**Location 3:**

**City:** San Antonio

**Country:** United States

**Facility:** The University of Texas Health Science Center at San Antonio

**State:** Texas

**Zip:** 78229

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
