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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02449837
Other study ID # LCCC1408
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2014
Est. completion date February 20, 2022

Study information

Verified date September 2022
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood draw
Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill, Department of Radiation Oncology Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To measure CTCs levels to evaluate the change pre- and post-treatment separately in 10 cohorts of patients receiving radiation therapy. 24 months post-radiation
Secondary Change in CTC levels from Baseline to Post-RT treatment and the correlation with local tumor response or pathological evaluation, depending on cohort 24 months post-radiation
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