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Blood Sample Collection for Experimental Blood Test to Track Liver Cancer

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ClinicalTrials.gov Identifier: NCT04720430
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Study Description
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Brief Summary:
This study investigates if an experimental blood test can help predict how well cancer will remain under control with treatment. Ther experimental blood test involves measuring mircoRNAs. MicroRNAs are small molecules which help regulate how genes are expressed. This information may help researchers guide treatment for other patients in the future.

Condition or disease
Hepatocellular Carcinoma

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Circulating MicroRNA Levels as a Predictor of Successful Bridging or Down-Staging Loco-Regional Therapy (LRT) to Liver Transplantation for Patients With Hepatocellular Carcinoma (HCC)
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : November 9, 2023
Estimated Study Completion Date : January 2024
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Patient Clinical Status - Liver Transplant [ Time Frame: At study completion, up to 12 months ]
    Undergoing liver transplant

  2. Patient Clinical Status - Death [ Time Frame: At study completion, up to 12 months ]
    Will assess the following: death

  3. Patient Clinical Status - Candidacy [ Time Frame: At study completion, up to 12 months ]
    No longer candidate for transplantation for reasons other than tumor progression

  4. Patient Clinical Status [ Time Frame: At study completion, up to 12 months ]
    No longer candidate for transplantation due to tumor progression despite loco-regional therapy efforts

  5. Incidence of "Wait List Drop Off" [ Time Frame: At study completion, up to 12 months ]
    Will be estimated and presented with a Clopper-Pearson exact binomial confidence interval


Secondary Outcome Measures :
  1. Time to "Wait List Drop Off" [ Time Frame: Up to 12 months ]
    Cox proportinal hazards modeling will be used to investigate the associations of each micro ribonucleic acid (miRNO) with time to "wait list drop off"

  2. Clinical Status of the subset of patients successfully reaching liver transplant [ Time Frame: At 1 year after transplantation ]
    Logistic regression modeling will be used to investigate the correlation of each miRNA with clincial status (alive without recurrence vs. recurrence or death) within one year of transplant will be cinducted in the subset of those undergoing transplant. The p-values will be adjusted for false discovery rate inflation by the methods of Benjamni & Hochberg (1995) for both secondary analyses, respectively


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patientss with hepatocellular carcinoma felt to be reasonable candidate for liver transplantation, potentially contingent on success of down-staging therapy
Criteria

Inclusion Criteria:

  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Definite diagnosis of hepatocellular carcinoma established (by standard radiographic or histologic criteria)
  • Felt to be reasonable candidate for liver transplantation, potentially contingent on success of down-staging therapy

Exclusion Criteria:

  • Either active or recent solid organ cancer other than hepatocellur carcinoma (HCC) within the last 5 years, unless determined by transplant hepatology team not to represent contra-indication to liver transplantation
  • Contra-indication to LRT (as assessed by interventional radiologist, for example severe thrombocytopenia, severe vascular disease precluding access, etc)
  • History of prior liver transplantation
  • Active or prior systemic therapy for HCC
Contacts and Locations
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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): NCT04720430


Contacts
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Contact: Jesse Civan, MD 215-955-8900 Jesse.Civan@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jesse Civan    215-955-8900    Jesse.Civan@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
More Information
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04720430    
Other Study ID Numbers: 19D.737
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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