NCT02412579

Brief Summary

The purpose of this study is to determine whether genetic markers unique to liver cancer are present and to assess usefulness as a diagnostic tool.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

7 years

First QC Date

April 6, 2015

Last Update Submit

July 19, 2022

Conditions

Hepatocellular Carcinoma

Keywords

HCCLiver Cancer

Outcome Measures

Primary Outcomes (1)

  • Using next-generation sequencing methods to detect isomiRs across different HCC cohorts at all stages undergoing liver transplantation.

    One year

Study Arms (2)

Hepatocellular Carcinoma with Cirrhosis

Subjects with hepatocellular carcinoma and cirrhosis.

Other: None - Standard of Care

Cirrhosis without Hepatocellular Carcinoma

Subjects with only cirrhosis.

Other: None - Standard of Care

Interventions

None - Standard of CareOTHER
Cirrhosis without Hepatocellular CarcinomaHepatocellular Carcinoma with Cirrhosis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hepatocellular Carcinoma Clinic Pre-Liver Transplant Clinic

You may qualify if:

  • Patients with the diagnosis of HCC who are on the wait list for liver transplantation
  • Patients with the diagnosis of HCC who have been admitted to hospital, scheduled to undergo liver transplantation within the following 24 hours.
  • Age Range: 18 to 75 years old

You may not qualify if:

  • Patients with metastatic HCC and patients with the diagnosis of HCC who are not on the wait list for liver transplantation.
  • Patients older than 75 years old and younger than 18 years old.
  • Patients who are unable to consent.
  • Pregnant patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Hepatocellular carcinoma tumor tissue Background liver tissue

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Peter Kim, M.D.

    Annette C. & Harold C. Simmons Transplant Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 9, 2015

Study Start

March 1, 2015

Primary Completion

March 17, 2022

Study Completion

March 17, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations

US(1)