Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Terminated by sponsor.)
Pathwork Diagnostics
Information provided by (Responsible Party):
John Hornberger, MD MS, Cedar Associates LLC Identifier:
First received: July 23, 2012
Last updated: March 4, 2013
Last verified: March 2013

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:

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


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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01649453

United States, California
Cedar Associates LLC
Menlo Park, California, United States, 94025
Sponsors and Collaborators
Cedar Associates LLC
Pathwork Diagnostics
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 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:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes processed this record on March 03, 2015