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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00977639
First received: September 15, 2009
Last updated: March 26, 2010
Last verified: March 2010

September 15, 2009
March 26, 2010
February 2008
June 2009   (final data collection date for primary outcome measure)
Not Provided
The fraction of TOO test results that are in agreement with "Clinical Truth" as determined by the PI following completion of standard of practice investigations to determine the tissue of origin.
Complete list of historical versions of study NCT00977639 on ClinicalTrials.gov Archive Site
Not Provided
  • To determine the fraction of TOO test results that are "indeterminate"
  • To assess the fraction of "Clinical Truth" determinations that is "off panel" (i.e. not one of the 15 tissues of origin tested for in the TOO test
  • To determine the fraction of TOO tests that leads to additional confirmatory diagnostic testing, or alters the final clinical diagnosis and/or clinical management
  • To determine the fraction of samples submitted for TOO testing in which the standard of care cannot determine a tissue of origin (unknown primary cancers)
Not Provided
Not Provided
 
Evaluation of Pathwork Tissue of Origin (TOO) Test for Human Malignancies
Evaluation of Pathwork Tissue of Origin (TOO) Test for Human Malignancies

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

a tissue biopsy specimen

Non-Probability Sample

Patients with a diagnosis of malignancy

Neoplasm Metastasis
Procedure: Pathwork TOO test
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
June 2009
June 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00977639
SU-03072008-1032, 98301, VAR0029
Not Provided
James L Zehnder, Stanford University School of Medicine
Stanford University
Not Provided
Principal Investigator: James L Zehnder Stanford University
Stanford University
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP