NCT00876408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

6 months

First QC Date

April 3, 2009

Last Update Submit

December 3, 2013

Conditions

Unknown Primary Cancer

Keywords

RT-PCR molecular profiling assayMolecular Profiling-Real Time Polymerase Chain ReactionUnknown PrimaryUPCCUP

Outcome Measures

Primary Outcomes (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.

    6 months

Secondary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frank A Greco, M.D.

    SCRI Development Innovations, LLC

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 6, 2009

Study Start

May 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2010

Last Updated

December 4, 2013

Record last verified: 2013-12

Locations

US(1)