POA Retrospective Repository

Solid Tumor, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03326479
• Other study ID #: COE-002-1116
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 19, 2017
• Last updated: October 26, 2017
• Start date: November 30, 2016
• Est. completion date: January 1, 2023

Study information

• Verified date: October 2017
• Source: Caris Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• 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 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.

Related Conditions & MeSH terms

• Oncology
• Solid Tumor, Adult

Intervention

Diagnostic Test:
• Caris Molecular Intelligence Profile
A comprehensive biomarker testing

Locations

Country	Name	City	State
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas

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