NCT02827552

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

March 13, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

2.9 years

First QC Date

July 6, 2016

Last Update Submit

February 9, 2021

Conditions

Cancer-related Problem/Condition

Keywords

pediatric oncologyradiotherapyradiosensitivity

Outcome Measures

Primary Outcomes (1)

  • skin fibroblast radiosenstivity

    residual double-strand breaks 24h after ex vivo radiation assessed with indirect immunofluorescence (gammaH2AX marker).

    up to 5 months

Secondary Outcomes (4)

  • early cutaneous, mucosal and hematological early radiation toxicity

    3 months

  • pATM nucleoshuttling

    up to 5 months

  • mean micronuclei number

    up to 5 months

  • late radiation toxicity

    15 years

Study Arms (1)

ARPEGE BioM

OTHER

N/A (not a randomized study)

Other: skin biopsy

Interventions

skin biopsyOTHER

skin biopsy performed prior radiation to characterize in blind the individual radiosensitivity of the patient

ARPEGE BioM

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children \< 18 years old
  • Patient with an indication of radiotherapy
  • Patient must be affiliated to a social security system
  • Patient under parental autority
  • Ability to provide an informed written consent form

You may not qualify if:

  • Contraindications for skin biopsy
  • Contraindications for radiotherapy
  • Referred to palliative radiotherapy
  • Prior radiotherapy in the same area
  • Indication of hypofractionated radiotherapy
  • Patient monitoring impossible
  • Patients deprived of liberty or under supervision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CHU de Besançon

Besançon, 25 000, France

Location

CHU de Dijon

Dijon, 21 000, France

Location

Georges-François-Leclerc

Dijon, 21 000, France

Location

Centre Léon Bérard

Lyon, 69 000, France

Location

CHU de Reims

Reims, 51 100, France

Location

Centre Paul Strauss

Strasbourg, 67 065, France

Location

Hôpital de Hautepierre

Strasbourg, 67 098, France

Location

CHRU toulouse

Toulouse, 31059, France

Location

IUCT Oncopole

Toulouse, 31059, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54 500, France

Location

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

  • Bernier-Chastagner V, Hettal L, Gillon V, Fernandes L, Huin-Schohn C, Vazel M, Tosti P, Salleron J, Francois A, Cerimele E, Perreira S, Peiffert D, Chastagner P, Vogin G. Validation of a high performance functional assay for individual radiosensitivity in pediatric oncology: a prospective cohort study (ARPEGE). BMC Cancer. 2018 Jul 6;18(1):719. doi: 10.1186/s12885-018-4652-7.

    PMID: 29976172DERIVED

Study Officials

  • VOGIN GUILLAUME, MD,PhD

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

  • BERNIER CHASTAGNER VALERIE, MD

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 11, 2016

Study Start

March 13, 2017

Primary Completion

February 7, 2020

Study Completion

February 7, 2020

Last Updated

February 12, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)