Securing Access to Innovative Molecules in Oncology and Hematology for Children Adolescents and Young Adults

STATUS

Recruiting
participants needed

450
sponsor

Gustave Roussy, Cancer Campus, Grand Paris

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Updated on 19 February 2024

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leukemia

plexiform neurofibroma

pediatric tumor

pediatric

NTRK

childhood fibrosarcoma

Summary

It involves collecting safety and efficacy data, under the actual conditions of use of medicines in children and adolescents, using a validated tool (VIGINOM) and relying on the network of Interregional pediatric oncology appeal organizations (OIR) identified by INCa since 2010 and responsible for the organization of Pluridisciplinary Pediatric Interregional (RCPPI) and National Consultative Meetings which discuss each case of relapse in order to define the best therapeutic options.

Description

The objective is to aim for completeness throughout the national territory. This is why this project will be carried out in close collaboration with the RIOs and RCPPI and that of the 31 centers of the SFCE which bring together more than 400 doctors pediatric oncologists and hematologists on French territory

Details

Condition	Pediatric Cancer
Age	25years or below
Treatment	data collection
Clinical Study Identifier	NCT04477681
Sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age 25 years old at the time of inclusion in the study
	Patient with a pediatric tumor or leukemia in therapeutic failure or relapse without standard therapeutic options. Exceptionally, patients on the first line of treatment without standard therapeutic options may also be included (eg g: inoperable plexiform neurofibroma and MEK inhibitors, childhood fibrosarcoma and NTRK inhibitors)
	Patient not eligible for an early phase clinical trial open to inclusion on French territory or refusal of inclusion
	Patient treated with a new drug discussed at an ICSID as part of an ATU (nominative or cohort) issued by the ANSM or an off-label prescription of a drug of interest already authorized in adults
	Patients treated in one of the SFCE centers authorized to prescribe chemotherapy
	Patient who did not object to participate after being informed of the study. The patient must be able and willing to cooperate in the study
Exclusion Criteria
	Patient included in an early phase clinical trial open to inclusions on French territory
	Oral refusal to participate by the patient or their legal representatives, in reading the information note specific to the study
	Patient under guardianship or curatorship, deprived of liberty or in the impossibility of expressing opposition to participating in the study

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Step 3 Enroll in the clinical study

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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Securing Access to Innovative Molecules in Oncology and Hematology for Children Adolescents and Young Adults