NCT04274868

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 10, 2015

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

10 years

First QC Date

February 17, 2020

Last Update Submit

February 17, 2020

Conditions

Liver Tumor

Outcome Measures

Primary Outcomes (1)

  • Establish a national bank of rare biological material

    Up to 10 years

Study Arms (1)

Children and adolescents with liver tumor

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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy

Villejuif, Val De Marne, 94800, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Brenda Mallon

CONTACT

0142114211branda.mallon@gustaveroussy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 18, 2020

Study Start

September 10, 2015

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)