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

March 4, 2013 updated by: John Hornberger, MD MS, Cedar Associates LLC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Menlo Park, California, United States, 94025
        • Cedar Associates LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community and academic clinics

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer of uncertain primary
Device: Pathwork® Tissue of Origin Test
Other Names:
  • Gene expression profile tissue of origin test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedar Associates LLC

Collaborators

Pathwork Diagnostics

Investigators

  • Principal Investigator: John Hornberger, MD MS, Cedar Associates LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

July 24, 2012

First Posted (Estimate)

July 25, 2012

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10043P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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