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

Review of Molecular Profiling-Real Time Polymerase Chain Reaction (Rt-Pcr) in Unknown Primary Cancer: Role in Clinical Management and Primary Site Prediction

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.

Study Overview

• Status: Completed
• Conditions: Unknown Primary Cancer

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37023
      • Tennessee Oncology, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Patients with RT-PCR testing completed since commercialization of the RT-PCR assay in 2007.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SCRI Development Innovations, LLC
• Collaborators: Biotheranostics, Inc.
• Investigators: Study Chair: Frank A Greco, M.D., SCRI Development Innovations, LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: April 3, 2009
• First Submitted That Met QC Criteria: April 3, 2009
• First Posted (Estimate): April 6, 2009

Study Record Updates

• Last Update Posted (Estimate): December 4, 2013
• Last Update Submitted That Met QC Criteria: December 3, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: CUP; RT-PCR molecular profiling assay; Molecular Profiling-Real Time Polymerase Chain Reaction; Unknown Primary; UPC
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasm Metastasis; Neoplasms; Neoplasms, Unknown Primary
• Other Study ID Numbers: SCRI OUTCOMES 08