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POA Prospective Repository

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ClinicalTrials.gov Identifier: NCT03324841
Recruitment Status : Enrolling by invitation
First Posted : October 30, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Caris Science, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Solid Tumor, Adult Oncology Diagnostic Test: Caris MI Profiling

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
MI Profiling
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Subjects who received Caris MI Profiling at one of the Precision Oncology Alliance (POA) sites
Criteria

Inclusion Criteria:

  • Subject's age must be greater than or equal to 18 years and must have received CMI testing

Exclusion Criteria:

  • Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients shall not be approached for participation.

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Caris Science, Inc.

Responsible Party: Caris Science, Inc.
ClinicalTrials.gov Identifier: NCT03324841     History of Changes
Other Study ID Numbers: COE-001-0815
First Posted: October 30, 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

Keywords provided by Caris Science, Inc.:
Molecular Profiling
Biomarker Analysis
Next Generation Sequencing