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Pediatric Hepatic Tumors (HEPATOBIO)

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ClinicalTrials.gov Identifier: NCT04274868
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Study Description
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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.

Condition or disease
Liver Tumor

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Years
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)
Actual Study Start Date : September 10, 2015
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

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


Outcome Measures
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Primary Outcome Measures :
  1. Establish a national bank of rare biological material [ Time Frame: Up to 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes 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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04274868


Contacts
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Contact: Brenda Mallon 0142114211 ext +33 branda.mallon@gustaveroussy.fr

Locations
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France
Gustave Roussy Recruiting
Villejuif, Val De Marne, France, 94800
Contact: Branda Mallon    0142114211 ext +33    branda.mallon@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
More Information
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT04274868    
Other Study ID Numbers: 2015-A00180-49
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases