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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:
Collaborator:
Pathwork Diagnostics
Information provided by (Responsible Party):
John Hornberger, MD MS, Cedar Associates LLC
ClinicalTrials.gov Identifier:
NCT01649453
First received: July 23, 2012
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Cedar Associates LLC:

Primary Outcome Measures:
  • Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: John Hornberger, MD MS, CEO, President, Cedar Associates LLC
ClinicalTrials.gov Identifier: NCT01649453     History of Changes
Other Study ID Numbers: 10043P
Study First Received: July 23, 2012
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cedar Associates LLC:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

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

ClinicalTrials.gov processed this record on June 18, 2013