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Caris Molecular Intelligence Registry (CMIR)

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ClinicalTrials.gov Identifier: NCT02678754
Recruitment Status : Terminated (Business decision to move away from this study)
First Posted : February 10, 2016
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Caris Science, Inc.

Brief 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.

Condition or disease Intervention/treatment
Solid Tumors Other: No intervention required, purely observational

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Study Type : Observational [Patient Registry]
Actual Enrollment : 4981 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 9 Months
Official Title: A Registry of Caris Life Sciences® Molecular Intelligence™ Service (Biomarker Assessment Results) Intended for Correlation With Cancer Clinical Outcomes
Study Start Date : February 2010
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : November 1, 2019



Primary Outcome Measures :
  1. Documentation of the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided. [ Time Frame: 5 years per patient ]


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
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients seen within a physician practice participating in the Registry are potential candidates if they meet the eligibility criteria requirements
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Additional Information:

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Responsible Party: Caris Science, Inc.
ClinicalTrials.gov Identifier: NCT02678754    
Other Study ID Numbers: TCREG-001-00-V2-1209
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020