Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Predictive Study of Radiation Induced Sarcoma (SARI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01504360
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Radiation Induced Sarcoma Genetic: tumor genetic predisposition to develop sarcoma assessment Not Applicable

Detailed Description:
The biological study will include the two following steps:1. On frozen specimen: genic profile of the tumor will be studied with two different techniques: CGH-array from extracted DNA in order to evaluate the number of gene copies, amplifications and deletions. The RNAm expression profile will be studied to evaluate the level of the gene expression. More than 200 data collected in Institut Bergonié, coming from de novo sarcoma would be used as a comparative specimen since the pathological diagnosis is the same as the one observed for radiation induced sarcoma. A comparison between the two populations will be able to define profiles, gene modifications and signalisation pathways of radiation induced sarcoma. 2. On blood sample: 2 groups of patients will be compared: those with radiation induced sarcoma and patients receiving radiation therapy for more than 5 years ago without developing sarcoma. The study will be performed with the inform consent of the patients and of the controlled cases.This second step requires 2 blood samples (2 x 5 ml). They will be collected and sent to the molecular biology laboratory located in Centre Alexis VAUTRIN (Nancy).- One sample of 5 mm will be dedicated to study radiation induced apoptosis assessed by flow cytometry. A correlation has been described between radiation-induced apoptosis of CT8+ lymphocytes after an 8 Gy irradiation and the occurrence of severe late toxicity after radiation therapy for patients treated for several types of tumors.- 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). This sample will be used after DNA extraction from mononuclear blood cells. DNA will be extracted and controlled by flow cytometrical separation. It will be sent to Bordeaux molecular biology laboratory in Institut Bergonié (Prof. JM COINDRE) to perform an evaluation of the single nucleotide polymorphism. The aim of this part of the protocol is to study variances in gene, the product of which plays a role in radiation response and in the development of adverse effects after radiation therapy. For patients with radiation-induced sarcoma, the results of this analysis will be compared with the data obtained from DNA analysis extracted from the tumors. The clinical, pathological and biological characterisation of radiation-induced sarcoma obtained will allow to identify constitutional variances linked with an increased sensitivity to radiation therapy leading to discuss indication of irradiation in a population at risk. Pediatric radiation therapy and adjuvant treatment after surgery for breast carcinoma will be the main targets of this selection of patients. This project will be able to select radiation modality in patients at risk (intensity modulated radiation therapy or 3D conformal approach, stereotactic approaches, partial irradiation of the breast).
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Predictive Study of Radiation Induced Sarcoma From the GSF-GETO Data Base.
Study Start Date : December 2011
Actual Primary Completion Date : July 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: sarcoma group
patient suffering form radiation-induced sarcoma
 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.
Active Comparator: free from sarcoma group
patient without sarcoma 5 years after radiation therapy
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Determine the predictive clinical and biological risk factors to develop a sarcoma on irradiated territory. [ Time Frame: from date of inclusion up to the end of recruiting period : november 2013 (anticipated) ]
    Clinical data of initial radiation therapy, radiation-induced apoptosis of CT8+ lymphocytes and polymorphism of the genes involved in reparation of DNA by using chip screening of single nucleotide polymorphisms (SNP) will be studied for each patient included.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

radiation-induced sarcoma group

Inclusion Criteria:

  1. Age > 18 ans when radiation was performed
  2. suffering from a radiation induced sarcoma

Exclusion Criteria:

  1. private individuals of freedom or under tutelage (including legal guardianship)
  2. initial tumor treated by radiotherapy was a sarcoma
  3. patient bearer of an osteosarcoma

Free from irradiation induced sarcoma group

Inclusion Criteria:

  1. Age > 18 ans when radiation was performed
  2. surviving irradiated patients for cancer for more than 5 years and free of from radiation-induced sarcoma.

Exclusion Criteria:

  1. private individuals of freedom or under tutelage (including legal guardianship)
  2. History of cancer (except baso-cellular cutaneous epithelioma or in situ epithelioma of the cervix) that has relapsed in the 5 years preceding recruitment for the trial
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504360


Locations
Layout table for location information
France
CGFL
Dijon, France, 21079
Sponsors and Collaborators
Centre Georges Francois Leclerc
Investigators
Layout table for investigator information
Principal Investigator: Phillipe Maingon, Professor Centre Georges Francois Leclerc
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT01504360    
Other Study ID Numbers: 0328-3maph11
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: April 2016
Keywords provided by Centre Georges Francois Leclerc:
sarcoma
radiation therapy
predictive essay
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms