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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT00977639
Collaborator
(none)
2
Enrollment
1
Location
16
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Procedure: Pathwork TOO test

Study Design

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 :
Feb 1, 2008
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: James L Zehnder, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00977639
    Other Study ID Numbers:
    • SU-03072008-1032
    • 98301
    • VAR0029
    First Posted:
    Sep 16, 2009
    Last Update Posted:
    Mar 29, 2010
    Last Verified:
    Mar 1, 2010
    Additional relevant MeSH terms:
    Neoplasm Metastasis

    Study Results

    No Results Posted as of Mar 29, 2010