Caris Molecular Intelligence Registry (CMIR)

January 21, 2020 updated by: Caris Science, Inc.

A Registry of Caris Life Sciences® Molecular Intelligence™ Service (Biomarker Assessment Results) Intended for Correlation With Cancer Clinical Outcomes

This data collection Registry is a multi-center, observational outcomes Database designed to collect data on the demographics, presentation, diagnosis, treatment, resource use, quality of life and outcomes of subjects utilizing Caris Molecular Intelligence™ Services for treatment of solid tumor cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4981

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients seen within a physician practice participating in the Registry are potential candidates if they meet the eligibility criteria requirements

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years, and
  • Solid Tumor analyzed by Caris Molecular Intelligence™ Service Profile(s) and/or Caris Next-Generation Sequencing

Exclusion Criteria:

  • Individual test orders; defined as single biomarker assessment
  • Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoner-patients shall not be approached for participation in the Registry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Documentation of the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided.
Time Frame: 5 years per patient
5 years per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caris Science, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • TCREG-001-00-V2-1209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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