Clinical Trial: Investigation of Circulating Tumor Cells From Cancer Patients Undergoing Radiation Therapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Investigation of Circulating Tumor Cells From Cancer Patients Undergoing Radiation Therapy

Brief Summary: The purpose of this study is to investigate the level of Circulating Tumor Cells (CTCs) in cancer patients before and after undergoing treatment regimens where the primary treatment modality is radiation therapy (XRT). Specifically, there is interest in the change in CTCs pre- and post- XRT, both in absolute and relative terms.

Detailed Summary: CTCs measurements will be taken pre- and post-RT treatment. CTCs measurements will also be taken during treatment. The CTCs measurements from this study will provide essential information for the power and sample size considerations for future translational studies, particularly for those looking to identify biomarkers possibly associated with CTCs and tumor response activity after XRT, and to adequately power more formal statistical comparisons of important associations between CTCs and patient characteristics and outcomes.
Sponsor: UNC Lineberger Comprehensive Cancer Center

Current Primary Outcome: To measure CTCs levels to evaluate the change pre- and post-treatment separately in patients with locally advanced head and neck, cervical, rectal, lung, prostate, or oligometastatic solid malignancies undergoing radiotherapy with or without chemotherapy [ Time Frame: 24 months post-radiation ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in CTC levels from Baseline to Post-RT treatment and the correlation with local tumor response or pathological evaluation, depending on cohort [ Time Frame: 24 months post-radiation ]

Original Secondary Outcome: Same as current

Information By: UNC Lineberger Comprehensive Cancer Center

Dates:
Date Received: April 7, 2015
Date Started: May 2014
Date Completion: May 2018
Last Updated: January 30, 2017
Last Verified: January 2017