POA Prospective 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: NCT03324841|
Recruitment Status : Enrolling by invitation
First Posted : October 30, 2017
Last Update Posted : October 31, 2017
|Condition or disease||Intervention/treatment|
|Solid Tumor, Adult Oncology||Diagnostic Test: Caris MI Profiling|
This repository is a multi-center, outcomes study designed to 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.
Prospective data will be obtained only from consented patients or patients who have died or have been lost to follow-up. Lost to follow-up is defined as a subject who has not returned for continued care or evaluation (e.g., disability, relocation or unresponsiveness). Site coordinators are required attempt to contact the subject 3 times before deeming them lost to follow up. Data collection and the protection of privacy are discussed in the Methods section below.
In addition to treatment and response data, initial diagnosis and staging results will be recorded as well as any recurrence information. As we are capturing the subject's cancer treatment as a whole, results from pertinent cancer-related tests performed by outside entities for eligible subjects will need to be collected by the site coordinator and maintained at the site accordingly for reporting and monitoring purposes.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10000 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository|
|Actual Study Start Date :||June 7, 2017|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2023|
Subjects must have undergone Caris MI Profiling in order to be eligible for the study. No required intervention is dictated by the protocol.
Diagnostic Test: Caris MI Profiling
Customized comprehensive biomarker testing
- Treatment outcomes of patients who had CMI performed [ Time Frame: 5 years per patient ]Documentation of the frequency of specific clinical events in relation to diagnosis, treatments and outcomes for patients who have had Caris Molecular profiling performed.
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): NCT03324841
|United States, Arkansas|
|Highlands Oncology Group|
|Fayetteville, Arkansas, United States, 72703|
|United States, Nebraska|
|Nebraska Cancer Specialists|
|Omaha, Nebraska, United States, 68130|
|United States, Tennessee|
|The West Clinic|
|Germantown, Tennessee, United States, 38138|
|United States, Texas|
|The University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229|