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

Neoplasm Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01649453
• Other study ID #: 10043P
• Status: Terminated
• Phase: N/A
• First received: July 23, 2012
• Last updated: March 4, 2013
• Start date: May 2012
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: Cedar Associates LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasm Metastasis

Intervention

Device:
• Pathwork® Tissue of Origin Test

Locations

Country	Name	City	State
United States	Cedar Associates LLC	Menlo Park	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedar Associates LLC	Pathwork Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		2 years	No