Predictive Study of Radiation Induced Sarcoma (SARI)

June 9, 2017 updated by: Centre Georges Francois Leclerc

Predictive Study of Radiation Induced Sarcoma From the GSF-GETO Data Base.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CGFL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
from date of inclusion up to the end of recruiting period : november 2013 (anticipated)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Georges Francois Leclerc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Phillipe Maingon, Professor, Centre Georges François Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0328-3maph11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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