Molecular Basis of Pediatric Liver Cancer

Hepatocellular Carcinoma Clinical Trial

Official title:

Genetic and Molecular Basis of Pediatric Liver Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03959800
• Other study ID #: STUDY20050018
• Status: Recruiting
• Start date: June 22, 2015
• Est. completion date: June 30, 2029

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: Morgan Paul, BSN
• Phone: (412) 692-8472
• Email: Morgan.Paul2[@]upmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this retrospective and prospective project is to understand the molecular and genetic basis of liver cancer of childhood. Understanding the molecular and genetic bases of liver cancers can offer a better classification based on tumor biology, mechanisms and predisposition.

Description:

Pediatric liver cancers are rare, affecting at times no more than 1 in one million population. Understanding the molecular basis of these cancers is important in order to develop more accurate diagnoses and more effective treatments. Current classifications of these cancers are based on how these cancers look on diagnostic studies such as radiologic imaging or under the microscope. Such a classification system does not explain why a particular cancer has a different outcome from what is considered "usual" for that particular cancer. Nor does such a classification system explain why two different classes of cancers behave the same way. Understanding the genetic bases of liver cancers can offer a better classification based on tumor biology, mechanisms and predisposition.

To achieve these goals, large numbers of such cancer patients or affected tissue must be collected. This is not possible in any single institution, or any single country. The current project will collect biological samples such as residual tumor tissue, saliva, or blood from affected patients and their biological parents and families, along with clinical information about the cancer. These biological samples will be used to study the genes and how these genes work in tumor tissue and in non-tumor tissue. The results of this study will permit childhood liver cancers to be categorized on the basis of common defects in genes and their function.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 99 Years

Eligibility

Inclusion Criteria:

• Prior or current treatment for a childhood liver tumor, malignant or benign, at age <21 years.

• Biological parents and siblings of eligible children.

Exclusion Criteria:

• No prior or current treatment for a childhood liver tumor.

• Non-biological parents, legal guardians, or non-biological siblings of eligible children.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Childhood Liver Cancer
• Embryonal Sarcoma of Liver (Disorder)
• Hepatoblastoma
• Hepatocellular Carcinoma
• Liver Malignant Tumors
• Liver Neoplasms
• Rhabdoid Tumor
• Rhabdoid Tumor of Liver

Locations

Country	Name	City	State
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene sequencing	DNA sequence variants	Recurrence free survival at 2 years
Primary	Gene expression analysis	Differentially expressed genes	Recurrence free survival at 2 years
Primary	Status of genome-wide chromatin accessibility	chromatin accessibility	Duration of active chemotherapy to two years after surgical treatment
Primary	Epigenetic change	Differential methylation	Duration of active chemotherapy to two years after surgical treatment
Primary	Tumor infiltrating cells which express immune checkpoints	differentially enriched immune cells	Duration of active chemotherapy to two years after surgical treatment
Secondary	Response to chemotherapy	Survival	Duration of active chemotherapy to two years after surgical treatment
Secondary	Response to chemotherapy	Relapse	Duration of active chemotherapy to two years after surgical treatment