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

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.
 
ClinicalTrials.gov Identifier: NCT00876408
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : December 4, 2013
Sponsor:
Collaborator:
bioTheranostics
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Brief Summary:
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 or disease
Unknown Primary Cancer

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Study Type : Observational
Actual Enrollment : 30 participants
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
Study Start Date : May 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2010



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]


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
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.

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
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United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
bioTheranostics
Investigators
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Study Chair: Frank A Greco, M.D. SCRI Development Innovations, LLC
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Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00876408    
Other Study ID Numbers: SCRI OUTCOMES 08
First Posted: April 6, 2009    Key Record Dates
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:
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Neoplasms, Unknown Primary
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes