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Review of Molecular Profiling-Real Time Polymerase Chain Reaction (Rt-Pcr) in Unknown Primary Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00876408
First Posted: April 6, 2009
Last Update Posted: December 4, 2013
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.
Collaborator:
bioTheranostics
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
  Purpose
This will be a retrospective review of 30 patients with unknown primary cancer who have had commercially available RT-PCR assays performed on biopsied tumors, in order to determine if the assay results are consistent with clinical features and useful for planning initial therapy or changing therapy.

Condition
Unknown Primary Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Review of Molecular Profiling-Real Time Polymerase Chain Reaction (Rt-Pcr) in Unknown Primary Cancer: Role in Clinical Management and Primary Site Prediction

Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • To correlate the tissue of origin predicted by the RT-PCR assay with clinical and pathologic features of patients with carcinoma of unknown primary site. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • To correlate the tissue of origin predicted by the RT-PCR with actual primary sites found subsequently in a subset of patients. [ Time Frame: 6 months ]
  • To evaluate the utility of RT-PCR assay results in guiding treatment selection in patients with carcinoma of unknown primary site. [ Time Frame: 6 months ]

Enrollment: 30
Study Start Date: May 2009
Study Completion Date: November 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 30 patients at Tennessee Oncology with unknown primary cancer have had commercially available RT-PCR assays done on their tissue biopsy since the assay became available in 2007. These patients are the subjects of this review.
Criteria

Inclusion Criteria:

  • Patients with RT-PCR testing completed since commercialization of the RT-PCR assay in 2007.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00876408


Locations
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
bioTheranostics
Investigators
Study Chair: Frank A Greco, M.D. SCRI Development Innovations, LLC
  More Information

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00876408     History of Changes
Other Study ID Numbers: SCRI OUTCOMES 08
First Submitted: April 3, 2009
First Posted: April 6, 2009
Last Update Posted: December 4, 2013
Last Verified: December 2013

Keywords provided by SCRI Development Innovations, LLC:
RT-PCR molecular profiling assay
Molecular Profiling-Real Time Polymerase Chain Reaction
Unknown Primary
UPC
CUP

Additional relevant MeSH terms:
Neoplasms, Unknown Primary
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes