POA Retrospective Repository
Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database
1 other identifier
observational
10,000
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2016
CompletedFirst Submitted
Initial submission to the registry
October 19, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedOctober 31, 2017
October 1, 2017
6.1 years
October 19, 2017
October 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Data Gathering
Documentation of the frequency of specific clinical events in relation to diagnosis, treatments and outcomes provided
5 years per patient
Study Arms (1)
Retrospective
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.
Interventions
Eligibility Criteria
Subject's who have had CMI testing prior to 11/11/2016 at one of the participating POA sites.
You may qualify if:
- 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.
You may not qualify if:
- Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients shall not be approached for participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2017
First Posted
October 31, 2017
Study Start
November 30, 2016
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
October 31, 2017
Record last verified: 2017-10