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

This study has been terminated.
(Terminated by sponsor.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01649453
First Posted: July 25, 2012
Last Update Posted: March 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pathwork Diagnostics
Information provided by (Responsible Party):
John Hornberger, MD MS, Cedar Associates LLC
  Purpose
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.

Condition Intervention
Neoplasm Metastasis Device: Pathwork® Tissue of Origin Test

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study of Clinical Outcomes for the Pathwork® Tissue of Origin Test

Further study details as provided by John Hornberger, MD MS, Cedar Associates LLC:

Primary Outcome Measures:
  • Survival [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Tissue biopsy specimen.

Enrollment: 19
Study Start Date: May 2012
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cancer of uncertain primary Device: Pathwork® Tissue of Origin Test
Other Name: Gene expression profile tissue of origin test

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community and academic clinics
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649453


Locations
United States, California
Cedar Associates LLC
Menlo Park, California, United States, 94025
Sponsors and Collaborators
Cedar Associates LLC
Pathwork Diagnostics
Investigators
Principal Investigator: John Hornberger, MD MS Cedar Associates LLC
  More Information

Responsible Party: John Hornberger, MD MS, CEO, President, Cedar Associates LLC
ClinicalTrials.gov Identifier: NCT01649453     History of Changes
Other Study ID Numbers: 10043P
First Submitted: July 23, 2012
First Posted: July 25, 2012
Last Update Posted: March 6, 2013
Last Verified: March 2013

Keywords provided by John Hornberger, MD MS, Cedar Associates LLC:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes