Clinical trial NCT03324841: POA Prospective Repository
Official title: Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solid Tumor, Adult
Oncology
Keywords: Molecular Profiling
Biomarker Analysis
Next Generation Sequencing
Lead sponsor: Caris Science, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-30
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who received Caris MI Profiling at one of the Precision Oncology Alliance (POA) sites

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.

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 the investigators 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.

Eligibility 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.

Primary outcomes:
measure: Effecting Change
timeFrame: within 5 years
measure: Performing retrospective research
timeFrame: within 5 years
measure: Evaluate the frequency of specific clinical events
timeFrame: within 5 years
measure: Provide information access that is vital to research collaborators
timeFrame: within 5 years
measure: Cultivate a repository for assay development
timeFrame: within 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Irvine
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
city: Washington
country: United States
facility: MedStar Health Research Institute, Inc.
state: District of Columbia
city: Orlando
country: United States
facility: AdventHealth Orlando Cancer Institute
state: Florida
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Cincinnati
country: United States
facility: University of Cincinnati Health, LLC
state: Ohio
city: Philadelphia
country: United States
facility: The Institute for Cancer Research dba The Research Institute of Fox Chase Cancer Center
state: Pennsylvania
city: Germantown
country: United States
facility: The West Clinic
state: Tennessee
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Caris Life Sciences
name: W. Michael Korn, MD
role: STUDY_DIRECTOR
References: