Clinical Trials Logo

Clinical Trial Summary

This study aims to explore prospectively the distribution of individual radiosensitivity in the pediatric population and to determine the predictive power of individual radiosensitivity biomarkers from an immunofluorescence technique on primary dermal fibroblasts


Clinical Trial Description

900 children and adolescents benefit from radiation each year in France. The mean age at diagnosis is 5 years; life expectancy for the 80% of them who could cure is long, and the incidence of radiation-related acute and mainly late complications - not evaluated to date - could exceed that of adults. Dysfunction of irradiated organs and growth disorders are specific to the pediatric subpopulation. Individual radiosensitivity of children and adolescents is unknown at this time, probably with large variability depending on the age when considering the changes in metabolic functions throughout growth. These complications are largely attributable to inter individual constitutional variations of cellular response to DNA damage. Subject to radiation-induced DNA damages such as double-strand breaks (DSB), cells reacts by triggering a whole series of phosphorylation events coordinated within multi protein complexes whose interplay is still misknown (DNA damage response i.e. DDR). Indirect Immunofluorescence cell scanning has revolutionized radiation biology research by permitting the detection of individual DSB in each cell nucleus in a dose range from 1 mGy to 10 Gy. This technique has notably confirmed that yield of unrepaired DSB is correlated with cell RS. From a broad spectrum of human radiosensitive skin fibroblast cell lines, the Inserm CRU 1052 team proposed a general model of DSB signaling and repair and a molecular assay to stratify patients according to their individual RS. ARPEGE biomarqueurs is a prospective multicenter study to prospectively evaluate with this assay the RS of children and adolescents treated over a year in all pediatric oncology departments of the Region Grand Est and set thresholds in this population. 150 children are thus potentially includable in different centers. The assay will be performed on primary fibroblasts cultured from a skin biopsy taken at diagnosis. The RS of patients will be measured in blind. Confusion factors such as irradiated volume, skin phototype, previous chemotherapy regimen, smoking, comorbities (diabetes, immunodeficiency, chronic inflammatory disease ...) will be reported. In parallel the RT-acute toxicity will be reported according to NCI-CTCAE v4.0 reference scale three months of the completion of RT then periodically during 15 years. Screening hypersensitive patients would be a major step forward in the management of cancers, opening a view to personalized medicine. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02827552
Study type Interventional
Source Institut de Cancérologie de Lorraine
Contact
Status Terminated
Phase N/A
Start date March 13, 2017
Completion date February 7, 2020

See also
  Status Clinical Trial Phase
Completed NCT04255225 - Making Activity Time for Cognitive Health N/A
Completed NCT01196442 - Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer N/A
Completed NCT04064151 - A Research Study for Latina Women Undergoing Breast Cancer Treatment N/A
Withdrawn NCT05344625 - Ketamine-Assisted PsychoTherapy ViAbility in Treating Cancer-related Emotional Distress Early Phase 1
Completed NCT01967836 - Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients N/A
Completed NCT03345264 - The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study N/A
Recruiting NCT03576274 - Combined Technology Enhanced Home Exercise Program and Other Non-pharmacological Intervention for Cancer Survivors N/A
Completed NCT03650322 - Effects of Yoga, Strength Training and Aerobic Exercise on Cognition in Adult Cancer Survivors N/A
Completed NCT03282214 - A Self-Management Energy Conservation Program for Cancer-Related Fatigue Phase 2
Completed NCT03194399 - Development of Personalized Health Care Service in Patients With Breast Cancer N/A
Terminated NCT00006994 - S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat Phase 3
Active, not recruiting NCT04533165 - Virtual Exercise Program to Reduce Cancer Related Fatigue N/A
Active, not recruiting NCT04950608 - Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care Phase 2
Completed NCT03645005 - A Research Study for Latina Women After Breast Cancer Treatment N/A
Recruiting NCT05226078 - The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients N/A
Recruiting NCT02823314 - Effectiveness of Medical Taping Concept in Cancer Patients Phase 0
Completed NCT04230941 - Memory and Attention Adaptation Training-Geriatrics (MAAT-G) N/A
Completed NCT03911921 - RSYR for Fatigue Reduction in Cancer Survivors Phase 2
Completed NCT03198754 - Programmed Environmental Illumination (PEI) of Hospital Rooms to Prevent/Reduce Cancer-Related Fatigue N/A
Completed NCT02468141 - Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients N/A