NCT04477681 Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults
| NCT ID | NCT04477681 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Condition | Pediatric Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,150 participants |
| Start Date | 2020-04-09 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,150 participants in total. It began in 2020-04-09 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
It involves collecting safety and efficacy data, under the actual conditions of use of medicines in children and adolescents, using a validated tool (Ennov EDC) and relying on the network of Interregional pediatric oncology appeal organizations (RIOs) 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.
Eligibility Criteria
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 a RCPPI as part of a compassionate use 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04477681 clinical trial?
This trial is open to participants of all sexes, up to 25 Years, studying Pediatric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04477681 currently recruiting?
Yes, NCT04477681 is actively recruiting participants. Contact the research team at pablo.berlanga@gustaveroussy.fr for enrollment information.
Where is the NCT04477681 trial being conducted?
This trial is being conducted at Villejuif, France, Amiens, France, Angers, France, Besançon, France and 11 additional locations.
Who is sponsoring the NCT04477681 clinical trial?
NCT04477681 is sponsored by Gustave Roussy, Cancer Campus, Grand Paris. The trial plans to enroll 1,150 participants.
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