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

This study has been completed.
Sponsor:
Collaborator:
bioTheranostics
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00876408
First received: April 3, 2009
Last updated: December 3, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00876408     History of Changes
Other Study ID Numbers: SCRI OUTCOMES 08
Study First Received: April 3, 2009
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014