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Predictive Study of Radiation Induced Sarcoma

NCT01504360 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2017-06-12

No results posted yet for this study

Summary

Development of sarcoma within or adjacent to radiation field is a well known event of poor prognosis and unknown risk factors. Advanced techniques of radiation therapy including intensity modulated radiation therapy, tomotherapy or Arc therapy are providing new modalities of radiation delivery that could be responsible for developing these induced tumors. There is little data on molecular biology of radiation induced sarcoma even if some tools are still available to characterize these types of tumors aiming to compare their profile to a sarcoma observed in non irradiated area. An update of the GETO-GCSF registry, currently called CONTICANET data base in the framework of EORTC, represents the backbone of the project. The next step should follow two axes, a clinical one based on the dosimetric analysis of the characteristics of delivered radiation therapy and the second one based on a molecular characterization of the sarcomas developed in irradiated field.The data base will be updated and organized through the CONTICANET network and the radiation oncologists involved in the treatment of soft tissue sarcoma. A retrospective analysis of the clinical data and the parameters describing the initial treatment will be registered using the methodology proposed by I. Diallo for radiation induced tumors developed in childhood. The most recent data will be extracted in DICOM format for intercomparison in a dedicated software.A centralized review of pathological specimens is planned to validate the correct classification of the tumors inside the current staging system developed for soft tissue sarcoma.

Conditions

  • Radiation Induced Sarcoma

Interventions

GENETIC

tumor genetic predisposition to develop sarcoma assessment

data concerning initial radiation and localisation of the sarcoma secondary developed will be collected. 2 blood samples (2 x 5 ml)will be collected. One sample of 5 mm will be dedicated to study radiation induced apoptosis assessed by flow cytometry. The second sample will be used to study the polymorphism of the genes involved in reparation of DNA by using chip screening of single nucleotide polymorphisms (SNP). DNA will be extracted and controlled by flow cytometrical separation.

GENETIC

tumor genetic predisposition to develop sarcoma assessment

data concerning initial radiation and data demonstrating the lack of secondary sarcoma will be collected . 2 blood samples (2 x 5 ml)will be collected. One sample of 5 mm will be dedicated to study radiation induced apoptosis assessed by flow cytometry. The second sample will be used to study the polymorphism of the genes involved in reparation of DNA by using chip screening of single nucleotide polymorphisms (SNP). DNA will be extracted and controlled by flow cytometrical separation.

Sponsors & Collaborators

  • Centre Georges Francois Leclerc

    lead OTHER

Principal Investigators

  • Phillipe Maingon, Professor · Centre Georges Francois Leclerc

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2016-07-31
Completion
2017-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01504360 on ClinicalTrials.gov