Evaluation of Pathwork Tissue of Origin (TOO) Test for Human Malignancies

Neoplasm Metastasis Clinical Trial

Official title:

Evaluation of Pathwork Tissue of Origin (TOO) Test for Human Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977639
• Other study ID #: SU-03072008-1032
• Secondary ID: 98301VAR0029
• Status: Completed
• Phase: N/A
• First received: September 15, 2009
• Last updated: March 26, 2010
• Start date: February 2008
• Est. completion date: June 2009

Study information

• Verified date: March 2010
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The pathworks tissue of origin test is a microarray-based test with the goal of identifying the tissue of origin in patients with metastatic tumors of unknown primary site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:1 Subjects must be at least 18 years old. The TOO test is designed to determine the tissue of origin of common adult malignancies. There are no gender/ethnic restrictions.

2 Patients with a diagnosis of malignancy established by pathologic review of H&E staining of tumor biopsy or tumor resection without definitive determination of tissue of origin as assessed by the PI. Samples must have been obtained within three months of enrollment, or the patient must still be under active evaluation for tissue of origin at the time of enrollment. There are no limitations on prior therapy and time from last prior therapy.

3 Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:1 Patients under the age of 18 are excluded. There are no exclusions based on gender/ethnicity.

2 There are no exclusion requirements due to co-morbid disease or incurrent illness, as needed.

3 Pregnancy or nursing participants will not be excluded from the study.

4 Patients with a diagnosis of leukemia including acute myelogenous leukemia, acute lymphocytic leukemia, hairy cell leukemia, chronic myelogenous leukemia and chronic lymphocytic leukemia are excluded from enrollment on this study. The TOO test does not cover these diagnoses.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasm Metastasis

Intervention

Procedure:
• Pathwork TOO test

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States,