A Prospective Study of Clinical Outcomes for the Pathwork... | NCT01649453

Studies
A Prospective Study of Clinical Outcomes for the Pathwork Tissue of Origin Test

NCT01649453

Sponsor

Cedar Associates LLC

Status

Terminated

Last Update Posted

Mar 6, 2013Estimated

Enrollment

19Actual

Phase

Not provided

Conditions

Neoplasm Metastasis

Interventions

Pathwork® Tissue of Origin Test

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

Mar 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated by sponsor.

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Jul 23, 2012

First Submission Date that Met QC Criteria

Jul 24, 2012

First Posted Date

Jul 25, 2012Estimated

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

Mar 4, 2013

Last Update Posted Date

Mar 6, 2013Estimated

Name	Class
Pathwork Diagnostics	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

The study prospectively assesses the change in cancer-specific clinical decisions and outcomes before and after physicians received results from the Pathwork® Tissue of Origin (TOO) Test for patients whose primary site of cancer origin is uncertain.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cancer of uncertain primary			Device: Pathwork® Tissue of Origin Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pathwork® Tissue of Origin Test	Device		Cancer of uncertain primary	Gene expression profile tissue of origin test

Measure	Description	Time Frame
Survival		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

their physician ordered or intends to order a Pathwork® TOO Test between May 2012 and December 2013
the patient is ≥ 18 years of age
the patient has given informed consent (online or verbal)
the patient is able to understand English.

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

Community and academic clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Hornberger, MD MS	Cedar Associates LLC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedar Associates LLC		Menlo Park	California	94025	United States

Condition Browse Module

MeSH Terms

ID	Term
D009362	Neoplasm Metastasis
D009369	Neoplasms
D009385	Neoplastic Processes
D010335	Pathologic Processes

Ancestor Terms

ID	Term
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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