Solid Tumor, AdultNCT03324841
POA Prospective Repository
An observational study of Solid Tumor, Adult and Oncology, run by Caris Science, Inc. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Oncology
- What is being tested?
- Caris MI Profiling
- How many people
- 10,000 participants
- Where
- 11 sitesUnited States
- Study dates
- 7 Jun 2017to 1 Jan 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Subjects who received Caris MI Profiling at one of the Precision Oncology Alliance (POA) sites
Who may be able to join
- Subject's age must be greater than or equal to 18 years and must have received CMI testing
Who cannot join
- Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients shall not be approached for participation.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Cincinnati Health, LLC
Cincinnati, Ohio, 45219
The West Clinic
Germantown, Tennessee, 38138
St. Joseph Heritage Healthcare
Irvine, California, 92612
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
AdventHealth Orlando Cancer Institute
Orlando, Florida, 32803
The Institute for Cancer Research dba The Research Institute of Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
John Wayne Cancer Institute
Santa Monica, California, 90404
HonorHealth
Scottsdale, Arizona, 85258
University of Arizona
Tucson, Arizona, 85719
MedStar Health Research Institute, Inc.
Washington D.C., District of Columbia, 20007
About this study
Official title: Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository
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.
Read the 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.
- Conditions
- Solid Tumor, Adult, Oncology
- Being tested
- Caris MI Profiling
- Keywords
- Molecular Profiling, Biomarker Analysis, Next Generation Sequencing
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caris MI ProfilingDiagnostic test
Customized comprehensive biomarker testing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Caris MI Profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effecting Change
Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment.
Measured: within 5 years
Performing retrospective research
Performing retrospective research including clinical presentation, treatment and outcomes. This eligible cohort includes select subjects who have already undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management.
Measured: within 5 years
Evaluate the frequency of specific clinical events
Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed.
Measured: within 5 years
Provide information access that is vital to research collaborators
Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms.
Measured: within 5 years
Cultivate a repository for assay development
Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
Measured: within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start7 Jun 2017
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Caris Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- W. Michael Korn, MD, Study director, Caris Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324841
- Sponsor's protocol ID
- COE-001-0815
- Status last verified
- Jan 2020
- First submitted
- 13 Oct 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository
- ClinicalTrials.gov ID
- NCT03324841
- Acronym / sponsor ID
- COE-001-0815
- Conditions
- Solid Tumor, Adult, Oncology
- Keywords
- Molecular Profiling, Biomarker Analysis, Next Generation Sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Caris Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MI Profiling | – | Diagnostic Test: Caris MI ProfilingSubjects must have undergone Caris MI Profiling in order to be eligible for the study. No required intervention is dictated by the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects who received Caris MI Profiling at one of the Precision Oncology Alliance (POA) sites
Key inclusion criteria (1 listed)
- Subject's age must be greater than or equal to 18 years and must have received CMI testing
Key exclusion criteria (1 listed)
- Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients shall not be approached for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caris MI ProfilingCustomized comprehensive biomarker testing | Diagnostic test | MI Profiling |
Primary outcome
Effecting Change
Time frame: within 5 years
Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment.
Performing retrospective research
Time frame: within 5 years
Performing retrospective research including clinical presentation, treatment and outcomes. This eligible cohort includes select subjects who have already undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management.
Evaluate the frequency of specific clinical events
Time frame: within 5 years
Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed.
Provide information access that is vital to research collaborators
Time frame: within 5 years
Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms.
Cultivate a repository for assay development
Time frame: within 5 years
Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. Michael Korn, MD study director
Caris Life Sciences
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, Adult and Oncology, run by Caris Science, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effecting Change (time frame: within 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.