NCT03959800

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress78%
Jun 2015Jun 2029

Study Start

First participant enrolled

June 22, 2015

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

13 years

First QC Date

May 15, 2019

Last Update Submit

September 5, 2025

Conditions

Keywords

HepatoblastomaHepatocellular CarcinomaPediatric Liver Cancer

Outcome Measures

Primary Outcomes (5)

  • Gene sequencing

    DNA sequence variants

    Recurrence free survival at 2 years

  • Gene expression analysis

    Differentially expressed genes

    Recurrence free survival at 2 years

  • Status of genome-wide chromatin accessibility

    chromatin accessibility

    Duration of active chemotherapy to two years after surgical treatment

  • Epigenetic change

    Differential methylation

    Duration of active chemotherapy to two years after surgical treatment

  • Tumor infiltrating cells which express immune checkpoints

    differentially enriched immune cells

    Duration of active chemotherapy to two years after surgical treatment

Secondary Outcomes (2)

  • Response to chemotherapy

    Duration of active chemotherapy to two years after surgical treatment

  • Response to chemotherapy

    Duration of active chemotherapy to two years after surgical treatment

Eligibility Criteria

Age0 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Living or deceased individuals who were diagnosed with a liver tumor, malignant or benign, during childhood (age \<21 years) and their biological parents and siblings.

You may qualify if:

  • Prior or current treatment for a childhood liver tumor, malignant or benign, at age \<21 years.
  • Biological parents and siblings of eligible children.

You may not qualify if:

  • No prior or current treatment for a childhood liver tumor.
  • Non-biological parents, legal guardians, or non-biological siblings of eligible children.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA: blood, saliva or liver tissue.

MeSH Terms

Conditions

Carcinoma, HepatocellularHepatoblastoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesNeoplasms, Complex and Mixed

Central Study Contacts

Daniel Pieratt, MPA

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 22, 2019

Study Start

June 22, 2015

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations