POA Retrospective Repository
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03326479|
Recruitment Status : Unknown
Verified October 2017 by Caris Science, Inc..
Recruitment status was: Enrolling by invitation
First Posted : October 31, 2017
Last Update Posted : October 31, 2017
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment|
|Oncology Solid Tumor, Adult||Diagnostic Test: Caris Molecular Intelligence Profile|
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.
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database|
|Actual Study Start Date :||November 30, 2016|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2023|
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.
Diagnostic Test: Caris Molecular Intelligence Profile
A comprehensive biomarker testing
- Data Gathering [ Time Frame: 5 years per patient ]Documentation of the frequency of specific clinical events in relation to diagnosis, treatments and outcomes provided
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients shall not be approached for participation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326479
|United States, Arkansas|
|Highlands Oncology Group|
|Fayetteville, Arkansas, United States, 72703|
|United States, Nebraska|
|Nebraska Cancer Specialists|
|Omaha, Nebraska, United States, 68130|
|United States, Texas|
|The University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229|
|Responsible Party:||Caris Science, Inc.|
|Other Study ID Numbers:||
|First Posted:||October 31, 2017 Key Record Dates|
|Last Update Posted:||October 31, 2017|
|Last Verified:||October 2017|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|