Pediatric Hepatic Tumors (HEPATOBIO)

Constitution of a Centralized Biological Resources Collection and Associated With a Clinical Database for Childhood Liver Tumors Diagnosed in France (Retrospective Collection From 1990 and Prospective)

Centralized biological collection of multicentric origin, retrospective and prospective of biological samples (tissues and fluids) taken within the framework of the diagnostic and therapeutic management of children and adolescents with liver tumor, and supported in the centers of French Society for Childhood Cancers (SFCE) with associated clinical database.

Study Overview

• Status: Recruiting
• Conditions: Liver Tumor

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Brenda Mallon; Phone Number: +33 0142114211; Email: branda.mallon@gustaveroussy.fr

Study Locations

• France
  • Val De Marne
    • Villejuif, Val De Marne, France, 94800
      • Recruiting
      • Gustave Roussy
      • Contact: Branda Mallon; Phone Number: +33 0142114211; Email: branda.mallon@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated after 01/01/1990 for a primary liver tumor before the age of 18.

Description

Inclusion Criteria:

1. - For inclusion in the clinical database:

   • Children and adolescents (≤18 years at diagnosis) suffering from a primary liver tumor diagnosed after 01/01/1990 and treated in France
   • Informed consent to the computerization of data signed by the patient or by parents or legal representatives if he is a minor.

2. - For inclusion in the biological collection (CRB Paris Sud):

   • Additional criteria:
   • Availability of biological samples (tumor tissue, healthy tissue, plasma and / or serum).
   • Informed consent to the use of biological remains signed by the patient or by parents or legal representatives if he is a minor.

3. - For the inclusion of deceased patients:

   • Obtaining consent or failing this, seeking non-opposition to the computerization of data (for inclusion in the database) and the use of biological remains (for inclusion in the biological collection) of the patient or both parents or the legal guardian if he is a minor.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children and adolescents with liver tumor; Patients treated after 01/01/1990 for a primary liver tumor before the age of 18.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Establish a national bank of rare biological material	Up to 10 years

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2015
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 2015-A00180-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No