Solid TumorsCMIRNCT02678754
Caris Molecular Intelligence Registry
An observational study of Solid Tumors, run by Caris Science, Inc..
Trial summary
This data collection Registry is a multi-center, observational outcomes Database designed to collect data on the demographics, presentation, diagnosis, treatment, resource use, quality of life and outcomes of subjects utilizing Caris Molecular Intelligence™ Services for treatment of solid tumor cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- How many people
- 4,981 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to 1 Nov 2019
- How long will I take part?
- 9 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients seen within a physician practice participating in the Registry are potential candidates if they meet the eligibility criteria requirements
Who may be able to join
- Age greater than or equal to 18 years, and
- Solid Tumor analyzed by Caris Molecular Intelligence™ Service Profile(s) and/or Caris Next-Generation Sequencing
Who cannot join
- Individual test orders; defined as single biomarker assessment
- Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoner-patients shall not be approached for participation in the Registry.
About this study
Official title: A Registry of Caris Life Sciences® Molecular Intelligence™ Service (Biomarker Assessment Results) Intended for Correlation With Cancer Clinical Outcomes
This data collection Registry is a multi-center, observational outcomes Database designed to collect data on the demographics, presentation, diagnosis, treatment, resource use, quality of life and outcomes of subjects utilizing Caris Molecular Intelligence™ Services for treatment of solid tumor cancer.
- Conditions
- Solid Tumors
- Being tested
- No intervention required, purely observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention required, purely observationalOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided.
Measured: 5 years per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startFeb 2010
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Why it stopped: Business decision to move away from this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 4,981 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Caris Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678754
- Sponsor's protocol ID
- TCREG-001-00-V2-1209
- Acronym
- CMIR
- Status last verified
- Jan 2020
- First submitted
- 13 Jan 2016
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry of Caris Life Sciences® Molecular Intelligence™ Service (Biomarker Assessment Results) Intended for Correlation With Cancer Clinical Outcomes
- ClinicalTrials.gov ID
- NCT02678754
- Acronym / sponsor ID
- CMIR / TCREG-001-00-V2-1209
- Conditions
- Solid Tumors
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision to move away from this study
- Enrolment
- 4,981 participants (actual)
- Lead sponsor
- Caris Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 10 Feb 2016 (estimated)
- 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 data collection Registry is a multi-center, observational outcomes Database designed to collect data on the demographics, presentation, diagnosis, treatment, resource use, quality of life and outcomes of subjects utilizing Caris Molecular Intelligence™ Services for treatment of solid tumor cancer.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients seen within a physician practice participating in the Registry are potential candidates if they meet the eligibility criteria requirements
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years, and
- Solid Tumor analyzed by Caris Molecular Intelligence™ Service Profile(s) and/or Caris Next-Generation Sequencing
Key exclusion criteria (2 listed)
- Individual test orders; defined as single biomarker assessment
- Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoner-patients shall not be approached for participation in the Registry.
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 |
|---|---|---|
| No intervention required, purely observational | Other | – |
Primary outcome
Documentation of the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided.
Time frame: 5 years per patient
Results and safety
The study was stopped early (reason given: Business decision to move away from this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
Related trials for Solid Tumors
RecruitingPhase 1/2
A Study to Investigate ALE.P02 as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Selected CLDN1+ Solid Tumors
Squamous Non-small-cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
RecruitingPhase 1
Study of SC-102 in Patients With Advanced Solid Tumors
Advanced Solid Cancers
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer
RecruitingPhase 1/2
A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)
Advanced Solid Tumors, Malignant Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumors, run by Caris Science, Inc..
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Business decision to move away from 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?
Documentation of the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided. (time frame: 5 years per patient). 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 23 Jan 2020.