- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02678754
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
16 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
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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