Validation of a high performance functional assay for individual radiosensitivity in pediatric oncology: a prospective cohort study (ARPEGE)

Abstract

Participants and recruitment Inclusion/non-inclusion criteria All children and adolescents treated with a curative intent in pediatric oncology and radiotherapy departments of the Grand-Est and Burgundy-Franche-Comté regions, France participating in the GE-HOPE network (i.e. Nancy, Reims, Dijon, Strasbourg and Besançon) as well as Lyon and Toulouse may be included according to the following inclusion criteria: 1) age < 18 years, 2) indication of RT as part of the local control strategy on the primary tumor, 3) standard fractionation (1.8–2.2 Gy/fraction, 5 sessions/week) irrespective of the technique and particle used, 4) patient affiliated to social security insurance, 5) patient and / or holder(s) of parental authority signed a written informed consent. Table 1 Chronogram and investigations of the ARPEGE study Inclusion Weekly follow-up during RT 3 months after RT Once/year during the 5 first years Every 2 years during the 10 next first End of study (15 years) Written Informed consent signature X Checking of inclusion and non-inclusion criteria X Inclusion X Clinical exam X X X X X X X X X X X X X Medical history X Biopsy X Blood sample X Toxicity recording X X X X X X X X X X X X Biopsy-related adverse events recording X X X X X X X X X X X X Blood sample-related adverse events recording X X X X X X X X X X X X Concurrent treatments recording X X X X X X X X X X X X X Anticipated completion of enrollment All patients should be included over a 30-month period. Intervention Biopsy After information and written consent from the holder(s) of parental authority and/or the child/adolescent, a 2–5 mm skin biopsy will be sampled under general anesthesia (provided for another purpose, e.g. bone marrow biopsy, lumbar puncture, central venous catheter…) or local anesthesia once the indication of RT is certain. According to inter-regional data updated in 2015, the inclusion potential would be 150 patients per year in the territory.