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Trial record 1 of 1 for:    NCT03203837
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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 : September 13, 2017
Sponsor:
Collaborator:
BTG International Inc.
Information provided by (Responsible Party):
Robert Lewandowski, Northwestern University

Brief Summary:
To analyze specific angiogenic, inflammatory and immune profiles in hepatocellular carcinoma patients who undergo radioembolization.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Other: Plasma collection

Detailed Description:
Patients who have planned lobar radioembolization (TheraSphere (TS)) and consent to this study will have peripheral blood samples collected pre-TS, post-TS, 4 hours post-TS, 24 hours post-TS, 3 days post-TS, 7 days post-TS and 30 days post-TS to analyze specific angiogenic, inflammatory and immune profiles.

Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarker Analyses in Hepatocellular Carcinoma Patients Treated With Therasphere®
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort Intervention/treatment
HCC patients
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Treatment Response- AFP [ Time Frame: 2 years ]
    Alphafetoprotein will be measured in ng/mL.

  2. Treatment Response - Imaging [ Time Frame: 2 years ]
    Lesions will be measured using mRECIST.

  3. Treatment Response- Time-to-Progression [ Time Frame: 2 years ]
    Time-to-progression will be measured in days.

  4. Treatment Response- Overall Survival [ Time Frame: 2 years ]
    Overall survival will be measured in days.


Biospecimen Retention:   Samples With DNA
Any leftover patient plasma samples collected for this study will be retained for future research which may or may not involve genetic testing.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with hepatocellular carcinoma who will be receiving lobar TheraSphere radioembolization.
Criteria

Inclusion Criteria:

  • Must have the diagnosis of HCC (biopsy or imaging criteria)
  • Must have planned lobar TheraSphere treatment
  • Must be able to give consent
  • Must have an ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2
  • Must have a life expectancy of ≥ 3 months
  • Women must not be pregnant with an acceptable contraception in premenopausal women
  • Must be > 4 weeks since prior radiation
  • Must be > 2 weeks since liver surgery
  • Must be ≥ 2 weeks post radiosensitizing chemotherapy or > 6 weeks since prior BCNU (carmustine) or Mitomycin-C

Exclusion Criteria:

  • Patients are excluded if they do not meet the inclusion criteria

Information from the National Library of Medicine

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


Contacts
Contact: Carlene del Castillo, RN 312-695-1518 carlene.castillo@northwestern.edu
Contact: Robert Lewandowski, MD 312-695-9121 r-lewandowski@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Carlene del Castillo, RN    312-695-1518    carlene.castillo@northwestern.edu   
Sub-Investigator: Laura Kulik, MD         
Sub-Investigator: Riad Salem, MD         
Sub-Investigator: Aparna Kalyan, MD         
Sponsors and Collaborators
Northwestern University
BTG International Inc.
Investigators
Principal Investigator: Robert Lewandowski, MD Northwestern University

Publications:

Responsible Party: Robert Lewandowski, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT03203837     History of Changes
Other Study ID Numbers: STU000201854
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert Lewandowski, Northwestern University:
Radioembolization
Y90
TheraSphere
HCC
Biomarker
Prognostic factor
Angiogenesis
Inflammatory
Liver

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases