Caris Molecular Intelligence Registry | NCT02678754

Studies
Caris Molecular Intelligence Registry

NCT02678754

Sponsor

Caris Science, Inc.

Status

Terminated

Last Update Posted

Jan 23, 2020Actual

Enrollment

4,981Actual

Phase

Not provided

Conditions

Solid Tumors

Interventions

No intervention required, purely observational

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business decision to move away from this study

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Nov 1, 2019Actual

Completion Date

Nov 1, 2019Actual

First Submitted Date

Jan 13, 2016

First Submission Date that Met QC Criteria

Feb 9, 2016

First Posted Date

Feb 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2020

Last Update Posted Date

Jan 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

9 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,981Actual

Name	Type	Description	Arm Group Labels	Other Names
No intervention required, purely observational	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Documentation of the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided.		5 years per patient

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients seen within a physician practice participating in the Registry are potential candidates if they meet the eligibility criteria requirements

Sampling Method

Probability Sample