Biomarker Analyses in Hepatocellular Carcinoma (HCC) Patients Treated With TheraSphere®
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|ClinicalTrials.gov Identifier: NCT03203837|
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : May 3, 2019
|Condition or disease||Intervention/treatment|
|Hepatocellular Carcinoma||Other: Plasma collection|
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Biomarker Analyses in Hepatocellular Carcinoma Patients Treated With Therasphere®|
|Actual Study Start Date :||July 5, 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
HCC patients treated with radioembolization. Plasma collection will be performed at 7 timepoints in relation to treatment.
Other: Plasma collection
We will be collecting plasma at 7 different timepoints in hepatocellular carcinoma patients that are treated with radioembolization.
- Percentage change in angiogenic, inflammatory and immune biomarkers [ Time Frame: 2 years ]The percent of change at 7 different timepoints for the following biomarkers will be calculated: Ang-2, FGFb, HB-EGF, HGF, PDGF-BB, PIGF, SDF-1, VEGF, VEGFC, IFNg, IL-1a, IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, TNFa trimer, CRP, TGFb1, EGFR, PD-1, PD-L1, CD45RA, CD127, HLA-DR, CD62L, CD3, CD8, CD197, CCR7, CD45RO, PD-L2, FOXP3, Perforin, Granzyme, TIA-1, CD14, CD107a, CD25, CD45, CD4, CD20 and CD56+16.
- Treatment Response- AFP [ Time Frame: 2 years ]Alphafetoprotein will be measured in ng/mL.
- Treatment Response - Imaging [ Time Frame: 2 years ]Lesions will be measured using mRECIST.
- Treatment Response- Time-to-Progression [ Time Frame: 2 years ]Time-to-progression will be measured in days.
- Treatment Response- Overall Survival [ Time Frame: 2 years ]Overall survival will be measured in days.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203837
|Contact: Carlene del Castillo, RNfirstname.lastname@example.org|
|Contact: Robert Lewandowski, MDemail@example.com|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Carlene del Castillo, RN 312-695-1518 firstname.lastname@example.org|
|Sub-Investigator: Laura Kulik, MD|
|Sub-Investigator: Riad Salem, MD|
|Sub-Investigator: Aparna Kalyan, MD|
|Principal Investigator:||Robert Lewandowski, MD||Northwestern University|