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

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. Identifier: NCT00977639
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : March 29, 2010
Information provided by:
Stanford University

Brief 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.

Condition or disease Intervention/treatment
Neoplasm Metastasis Procedure: Pathwork TOO test

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Pathwork Tissue of Origin (TOO) Test for Human Malignancies
Study Start Date : February 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Biospecimen Retention:   Samples With DNA
a tissue biopsy specimen

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of malignancy

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.

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 identifier (NCT number): NCT00977639

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Principal Investigator: James L Zehnder Stanford University

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Responsible Party: James L Zehnder, Stanford University School of Medicine Identifier: NCT00977639    
Other Study ID Numbers: SU-03072008-1032
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: March 29, 2010
Last Verified: March 2010
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes