POA Retrospective Repository | NCT03326479

Studies
POA Retrospective Repository

NCT03326479

Sponsor

Caris Science, Inc.

Status

Unknown status

Last Update Posted

Oct 31, 2017Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Oncology
Solid Tumor, Adult

Interventions

Caris Molecular Intelligence Profile

Countries

United States

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

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2016Actual

Primary Completion Date

Jan 1, 2023Estimated

Completion Date

Jan 1, 2023Estimated

First Submitted Date

Oct 19, 2017

First Submission Date that Met QC Criteria

Oct 26, 2017

First Posted Date

Oct 31, 2017Actual

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

Oct 26, 2017

Last Update Posted Date

Oct 31, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 repository is a multi-center, outcomes study designed to retrospectively 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.

Detailed Description

Patients who have had CMI testing prior to the initial IRB submission date of November 11, 2016 for the respective site would be eligible to have their treatment and treatment response data entered into the study Database. All entered data would be de-identified. The patient's CMI biomarker results and treatment response data will be coupled together in order to allow the investigation of research questions concerning biomarker status and treatment response.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Retrospective		Subject who have previously had MI Profiling performed prior to 11/11/2016 are eligible for this study. No drug intervention is required for this study.	Diagnostic Test: Caris Molecular Intelligence Profile

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caris Molecular Intelligence Profile	Diagnostic Test	A comprehensive biomarker testing	Retrospective

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Data Gathering	Documentation of the frequency of specific clinical events in relation to diagnosis, treatments and outcomes provided	5 years per patient

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject' s age must be greater than or equal to 18 years and must have received CMI testing prior to the initial protocol IRB submission date of November 11, 2016.

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.

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

Subject's who have had CMI testing prior to 11/11/2016 at one of the participating POA sites.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Highlands Oncology Group		Fayetteville	Arkansas	72703	United States
Nebraska Cancer Specialists

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided