Pediatric Hepatic Tumors

Liver Tumor Clinical Trial

— HEPATOBIO  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04274868
• Other study ID #: 2015-A00180-49
• Status: Recruiting
• Start date: September 10, 2015
• Est. completion date: September 2025

Study information

• Verified date: February 2020
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Brenda Mallon
• Phone: 0142114211
• Email: branda.mallon[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver Tumor

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish a national bank of rare biological material		Up to 10 years