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Completed

NCT Number: NCT00876408

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

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.

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Key information

Conditions

Unknown Primary Cancer Neoplasm Metastasis Neoplasms Neoplasms, Unknown Primary Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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.

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Biotheranostics, Inc.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Apr 6, 2009
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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