iTHER 2.0: Clinical implementation of a pediatric cancer precision medicine program, enforced with personalized models.

Recruiting

• Conditions: Relapsed/refractory pediatric cancer, which was established by standard diagnostic methods OR initially diagnosed pediatric cancer patients for whom no standard treatment strategy is available or who have a dismal outcome with current treatment protocols.

• Registration Number: NL-OMON28323
• Lead Sponsor: Prinses Máxima Centrum voor kinderoncologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 380

Inclusion Criteria

•Relapsed/refractory pediatric cancer, which was established by standard diagnostic methods OR initially diagnosed pediatric cancer patients for whom no standard treatment strategy is available or who have a dismal outcome with current treatment protocols. In the case of very high risk primary disease, the results obtained in the frame of this study may be used at the physician’s discretion to improve a standard treatment strategy and may be applied a at later time point.
•A tissue sample or tumor DNA/RNA as well as normal DNA was obtained as standard of care at diagnosis, resection or at the event of refractory or relapsed disease or is planned with the purpose to confirm the diagnosis or a suspected relapse/refractory disease.
•Life-expectancy of at least 12 weeks.
•Written informed consent according to local law and legislation
•Age <30 years.

Exclusion Criteria

•Patients cannot participate in this study if there is no tissue or DNA/RNA available.
•If patients and parents do not want to be informed about detected germline abnormalities

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the objective response rates (complete response (CR), very good partial response (VGPR) or partial response (PR)) in pediatric patients with very high risk, relapsed or refractory tumors harboring actionable genomic alterations, treated with pathway-targeting agents compared to a non-treated cohort.