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

Unknown Primary Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876408
• Other study ID #: SCRI OUTCOMES 08
• Status: Completed
• Phase: N/A
• First received: April 3, 2009
• Last updated: December 3, 2013
• Start date: May 2009
• Est. completion date: November 2010

Study information

• Verified date: December 2013
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Neoplasms, Unknown Primary
• Unknown Primary Cancer

Locations

Country	Name	City	State
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	bioTheranostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To correlate the tissue of origin predicted by the RT-PCR with actual primary sites found subsequently in a subset of patients.		6 months	No
Secondary	To evaluate the utility of RT-PCR assay results in guiding treatment selection in patients with carcinoma of unknown primary site.		6 months	No