## Protocol Section
### Identification Module
**NCT ID:** NCT02412579

**Brief Title:** Genetic Profiling of Liver Cancer in Patients Undergoing Liver Transplantation

**Official Title:** Circulating MicroRNA Isoforms as Biomarkers in Hepatocellular Carcinoma and Associated Liver Transplantation

#### Organization Study ID Info
**ID:** 014-121
#### Organization
**Class:** OTHER
**Full Name:** Baylor Research Institute
### Status Module
#### Completion Date
**Date:** 2022-03-17

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-07-20

**Type:** ACTUAL

**Last Update Submit Date:** 2022-07-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-03-17

**Type:** ACTUAL

#### Start Date
**Date:** 2015-03

**Type:** ACTUAL

**Status Verified Date:** 2022-07

#### Study First Post Date
**Date:** 2015-04-09
**Type:** ESTIMATED
**Study First Submit Date:** 2015-04-06
**Study First Submit QC Date:** 2015-04-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Baylor Research Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** Hepatocellular carcinoma (HCC) is the most common form of liver cancer and a growing trend worldwide. Decision-making regarding treatment for patients is limited by the lack of clinically actionable biomarkers. This is pronounced in the case for determining and monitoring liver transplant recipients. In an effort to improve diagnosis, the use of circulating serum-based microRNA isoforms (isomiRs) can serve as non-invasive, screening biomarkers in HCC patients pre- and post-transplantation of the liver.

### Conditions Module

**Conditions:**

- Hepatocellular Carcinoma

**Keywords:**

- HCC

- Liver Cancer

### Design Module

#### Bio Spec

**Description:** Hepatocellular carcinoma tumor tissue Background liver tissue

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects with hepatocellular carcinoma and cirrhosis.

**Intervention Names:**

- Other: None - Standard of Care

**Label:** Hepatocellular Carcinoma with Cirrhosis

#### Arm Group 2

**Description:** Subjects with only cirrhosis.

**Intervention Names:**

- Other: None - Standard of Care

**Label:** Cirrhosis without Hepatocellular Carcinoma

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cirrhosis without Hepatocellular Carcinoma

- Hepatocellular Carcinoma with Cirrhosis

**Name:** None - Standard of Care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Time Frame:** One year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Hepatocellular Carcinoma Clinic Pre-Liver Transplant Clinic

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Dallas

**Country:** United States

**Facility:** Baylor University Medical Center

**State:** Texas

**Zip:** 75246

#### Overall Officials

**Official 1:**

**Affiliation:** Annette C. & Harold C. Simmons Transplant Institute

**Name:** Peter Kim, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000008113

- Term: Liver Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000008107

- Term: Liver Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M9613

- Name: Carcinoma, Hepatocellular

- Relevance: HIGH

- As Found: Hepatocellular Carcinoma

- ID: M11113

- Name: Liver Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000006528

- Term: Carcinoma, Hepatocellular

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
