<section>  <title value="1. PROTOCOL SPONSOR" /> <code> <coding>  <system value="http://spor.ema.europa.eu/v1/example-sections" /> <code value="00000021211" /> <display value="Protocol Sponsor" /> </coding> </code>  <text>  <status value="additional" />    <div xmlns="http://www.w3.org/1999/xhtml"> <div>It is responsibility of each participating national Group or Institution to arrange sponsorship in line with the requirements of the European Union directive on Good Clinical Practice in Clinical Trials.</div> </div> </text> </section> <section>  <title value="2. Protocol Co-ordination" /> <code> <coding>  <system value="http://spor.ema.europa.eu/v1/example-sections" /> <code value="00000021212" /> <display value="Protocol Co-ordination" /> </coding> </code>  <text>  <status value="additional" />    <div xmlns="http://www.w3.org/1999/xhtml"> <p>This protocol is co-ordinated by the European paediatric Soft tissue sarcoma Study Group (in its abbreviated form EpSSG). This new collaborative structure has been founded by</p> <ul> <li>The Co-operative Weichteilsarkom Studie (CWS)</li> <li>The AIEOP Soft Tissue Sarcoma Committee (AIEOP STSC)<br /><span>(former ICG: Italian Cooperative Group for paediatric soft tissue sarcoma)</span></li> <li>The SIOP Malignant Mesenchymal Tumour Committee (SIOP MMT)</li> </ul> <p>These Groups decided to join forces to design and implement a portfolio of pan-European studies addressed at children and adolescents affected by soft tissue sarcoma.</p> <p>This study will not introduce or try to license chemotherapeutic agents for treatment of paediatric sarcoma. Treatment will rely on already licensed and introduced chemotherapeutic drugs. Therefore, chemotherapeutic agents and other therapeutic substances needed for treatment in EpSSG RMS 2005 will not be paid for by the study nor will these substances be provided by pharmaceutical companies.</p> </div> </text> </section> <section> <title value="6. Summary" /> <code> <coding>  <system value="http://spor.ema.europa.eu/v1/example-sections" /> <code value="0000002223336" /> <display value="Summary" /> </coding> </code> <text> <status value="additional" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p>Three Cooperative Groups have been working in Europe on paediatric soft tissue sarcoma for the last twenty years: the SIOP MMT Committee, the CWS and the AIEOP STSC (former ICG). Cooperation has intensified over the last few years and has led to the foundation of the European paediatric Soft tissue sarcoma Study Group (EpSSG). This is the first EpSSG protocol and it addresses the treatment of children and young people presenting with non-metastatic rhabdomyosarcoma.</p> </div> </text>  <section> <title value="PATIENTS ELIGIBILITY" /> <code> <coding> <system value="http://spor.ema.europa.eu/v1/example-sections" /> <code value="0000005557" /> <display value="Eligibility" /> </coding> </code> <text> <status value="additional" /> <div xmlns="http://www.w3.org/1999/xhtml"> <p>A) To the observational study</p> <ul> <li>Patients with pathologically confirmed rhabdomyosarcoma</li> <li>No evidence of metastatic disease</li> <li>Age 0 - < 21 years</li> </ul> </div> </text> </section> </section>  </Composition> </resource> </entry> <entry> <fullUrl value="urn:uuid:812a430c-0eda-4615-a30b-a760edaa3597" /> <resource> <ResearchStudy> <id value="study-id" /> <identifier> <system value="https://eudract.europa.eu/example/identifier" /> <value value="RMS2005" /> </identifier> <title value="A Protocol for Non Metastatic Rhabdomyosarcoma" /> <status value="active" /> <condition> <coding> <system value="http://snomed.info/sct" /> <code value="302847003" /> <display value="Rhabdomyosarcoma" /> </coding> </condition> <descriptionSummary value="To give a homogenous local and systemic treatment Europe-wide according to the risk of local and metastatic relapse in patients categorized in Low, Standard and Very High Risk Groups (observational study)"></descriptionSummary>   <associatedParty> <name value="The Co-operative Weichteilsarkom Studie (CWS)" /> <role> <coding> <system value="http://hl7.org/fhir/CodeSystem/ResearchStudyPartyRole"></system> <code value="collaborator" /> <display value="Collaborator" /> </coding> </role> </associatedParty> <associatedParty> <name value="The AIEOP Soft Tissue Sarcoma Committee (AIEOP STSC)" /> <role> <coding> <system value="http://hl7.org/fhir/CodeSystem/ResearchStudyPartyRole"></system> <code value="collaborator" /> <display value="Collaborator" /> </coding> </role> </associatedParty> <associatedParty> <name value="The SIOP Malignant Mesenchymal Tumour Committee (SIOP MMT)" /> <role> <coding> <system value="http://hl7.org/fhir/CodeSystem/ResearchStudyPartyRole"></system> <code value="collaborator" /> <display value="Collaborator" /> </coding> </role> </associatedParty>  <recruitment> <targetNumber value="20" /> <actualNumber value="19" /> <eligibility> <reference value="EvidenceVariable/evidence-variable" /> </eligibility> </recruitment> </ResearchStudy> </resource> </entry> <entry> <resource> <EvidenceVariable> <id value="evidence-variable" /> <title value="Patients for Rhabdomyosarcoma Study" /> <status value="active" /> <characteristic> <description value="Patients with pathologically confirmed rhabdomyosarcoma" /> <definitionCodeableConcept> <coding> <system value="http://snomed.info/sct" /> <code value="302847003" /> <display value="Rhabdomyosarcoma" /> </coding> </definitionCodeableConcept> </characteristic> <characteristic> <description value="Age 0 - < 21 years" /> <definitionReference> <reference value="Group/group-id" /> </definitionReference> </characteristic> </EvidenceVariable> </resource> </entry> <entry> <resource> <Group> <id value="group-id" /> <type value="person" /> <membership value="definitional" /> <code> <coding> <system value="http://hl7.org/fhir/CodeSystem/GroupKind" /> <code value="cohort" /> </coding> </code> <characteristic> <code> <coding> <system value="http://hl7.org/fhir/CodeSystem/GroupCharacteristicKind" /> <code value="age-range" /> </coding> </code> <valueRange> <low> <value value="0" /> <unit value="year" /> </low> <high> <value value="21" /> <unit value="year" /> </high> </valueRange> <exclude value="false" /> </characteristic> </Group> </resource> </entry> </Bundle>


        
          
          
        
        
        
        
          
            
            
          
        
        
        <!-- main sections of the document, to follow the template -->
        <section>
          <!-- Section 1-->
          <title value="1. PROTOCOL SPONSOR" />
          <code>
            <coding>
              <!-- sections will all have codes to identify them -->
              <system value="http://spor.ema.europa.eu/v1/example-sections" />
              <code value="00000021211" />
              <display value="Protocol Sponsor" />
            </coding>
          </code>
          <!-- text is optional, if this is just a heading it may not be necessary -->
          <text>
            <!-- Section 1 -->
            <status value="additional" />
            <!-- HTML goes here, must start with
									<div xmlns="http://www.w3.org/1999/xhtml">
									-->
            <!-- any xhtml is valid, with a few exceptions
											(e.g. head, body, scripts etc).
										    See http://hl7.org/fhir/narrative.html#Narrative -->
            <!-- Doc: 1 Section: 1 Subsection: 0-->
            <div xmlns="http://www.w3.org/1999/xhtml">
              <div>It is responsibility of each participating national Group or Institution to arrange sponsorship in line with the requirements of the European Union directive on Good Clinical Practice in Clinical Trials.</div>
            </div>
          </text>
        </section>
        <section>
          <!-- Section 2 -->
          <title value="2. Protocol Co-ordination" />
          <code>
            <coding>
              <!-- sections will all have codes to identify them -->
              <system value="http://spor.ema.europa.eu/v1/example-sections" />
              <code value="00000021212" />
              <display value="Protocol Co-ordination" />
            </coding>
          </code>
          <!-- text is optional, if this is just a heading it may not be necessary -->
          <text>
            <!-- Section 1-->
            <status value="additional" />
            <!-- HTML goes here, must start with
									<div xmlns="http://www.w3.org/1999/xhtml">
									-->
            <!-- any xhtml is valid, with a few exceptions
											(e.g. head, body, scripts etc).
										    See http://hl7.org/fhir/narrative.html#Narrative -->
            <!-- Doc: 1 Section: 1 Subsection: 0-->
            <div xmlns="http://www.w3.org/1999/xhtml">
              <p>This protocol is co-ordinated by the European paediatric Soft tissue sarcoma Study Group (in its abbreviated form EpSSG). This new collaborative structure has been founded by</p>
              <ul>
                <li>The Co-operative Weichteilsarkom Studie (CWS)</li>
                <li>The AIEOP Soft Tissue Sarcoma Committee (AIEOP STSC)<br /><span>(former ICG: Italian Cooperative Group for paediatric soft tissue sarcoma)</span></li>
                <li>The SIOP Malignant Mesenchymal Tumour Committee (SIOP MMT)</li>
              </ul>
              <p>These Groups decided to join forces to design and implement a portfolio of pan-European studies addressed at children and adolescents affected by soft tissue sarcoma.</p>
              <p>This study will not introduce or try to license chemotherapeutic agents for treatment of paediatric sarcoma.  Treatment  will  rely  on  already  licensed  and  introduced  chemotherapeutic  drugs. Therefore,  chemotherapeutic  agents  and  other  therapeutic  substances  needed  for  treatment  in EpSSG RMS 2005 will not be paid for by the study nor will these substances be provided by pharmaceutical companies.</p>
            </div>
          </text>
        </section>
        <section>
          <title value="6. Summary" />
          <code>
            <coding>
              <!-- sections will all have codes to identify them -->
              <system value="http://spor.ema.europa.eu/v1/example-sections" />
              <code value="0000002223336" />
              <display value="Summary" />
            </coding>
          </code>
          <text>
            <status value="additional" />
            <div xmlns="http://www.w3.org/1999/xhtml">
              <p>Three Cooperative Groups have been working in Europe on paediatric soft tissue sarcoma for the last twenty years: the SIOP MMT Committee, the CWS and the AIEOP STSC (former ICG). Cooperation has intensified over the last few years and has led to the foundation of the European paediatric Soft tissue sarcoma Study Group (EpSSG). This is the first EpSSG protocol and it addresses the treatment of children and young people presenting with non-metastatic rhabdomyosarcoma.</p>
            </div>
          </text>
          <!-- Sub-section -->
          <section>
            <title value="PATIENTS ELIGIBILITY" />
            <code>
              <coding>
                <system value="http://spor.ema.europa.eu/v1/example-sections" />
                <code value="0000005557" />
                <display value="Eligibility" />
              </coding>
            </code>
            <text>
              <status value="additional" />
              <div xmlns="http://www.w3.org/1999/xhtml">
                <p>A) To the observational study</p>
                <ul>
                  <li>Patients with pathologically confirmed rhabdomyosarcoma</li>
                  <li>No evidence of metastatic disease</li>
                  <li>Age 0 - < 21 years</li>
                </ul>
              </div>
            </text>
          </section>
        </section>
        <!-- sections can repeat as necessary -->
      </Composition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:812a430c-0eda-4615-a30b-a760edaa3597" />
    <resource>
      <ResearchStudy>
        <id value="study-id" />
        <identifier>
          <system value="https://eudract.europa.eu/example/identifier" />
          <value value="RMS2005" />
        </identifier>
        <title value="A Protocol for Non Metastatic Rhabdomyosarcoma" />
        <status value="active" />
        <condition>
          <coding>
            <system value="http://snomed.info/sct" />
            <code value="302847003" />
            <display value="Rhabdomyosarcoma" />
          </coding>
        </condition>
        <descriptionSummary value="To give a homogenous local and systemic treatment Europe-wide according to the risk of local and                   metastatic  relapse  in  patients  categorized  in  Low,  Standard  and  Very  High  Risk  Groups                   (observational study)"></descriptionSummary>
        <!--sponsor>
                  <display value="European paediatric Soft tissue sarcoma Study Group (EpSSG)"/>
                </sponsor-->
        <!--classification>
                  <type>
                    <text value="Observational Study Model"/>
                  </type>
                  <classifier>
                    <text value="Cohort"/>
                  </classifier>
                </classification-->
        <associatedParty>
          <name value="The Co-operative Weichteilsarkom Studie (CWS)" />
          <role>
            <coding>
              <system value="http://hl7.org/fhir/CodeSystem/ResearchStudyPartyRole"></system>
              <code value="collaborator" />
              <display value="Collaborator" />
            </coding>
          </role>
        </associatedParty>
        <associatedParty>
          <name value="The AIEOP Soft Tissue Sarcoma Committee (AIEOP STSC)" />
          <role>
            <coding>
              <system value="http://hl7.org/fhir/CodeSystem/ResearchStudyPartyRole"></system>
              <code value="collaborator" />
              <display value="Collaborator" />
            </coding>
          </role>
        </associatedParty>
        <associatedParty>
          <name value="The SIOP Malignant Mesenchymal Tumour Committee (SIOP MMT)" />
          <role>
            <coding>
              <system value="http://hl7.org/fhir/CodeSystem/ResearchStudyPartyRole"></system>
              <code value="collaborator" />
              <display value="Collaborator" />
            </coding>
          </role>
        </associatedParty>
        <!--statusDate>
                  <activity>
                    <coding>
                      <system value="http://terminology.hl7.org/CodeSystem/research-study-statusDate-activity"/>
                      <code value="registration-submission"/>
                      <display value="Registration submission"/>
                    </coding>
                  </activity>
                  <actual value="true"/>
                  <period>
                    <start value="2012-05"/>
                  </period>
                </statusDate-->
        <recruitment>
          <targetNumber value="20" />
          <actualNumber value="19" />
          <eligibility>
            <reference value="EvidenceVariable/evidence-variable" />
          </eligibility>
        </recruitment>
      </ResearchStudy>
    </resource>
  </entry>
  <entry>
    <resource>
      <EvidenceVariable>
        <id value="evidence-variable" />
        <title value="Patients for Rhabdomyosarcoma Study" />
        <status value="active" />
        <characteristic>
          <description value="Patients with pathologically confirmed rhabdomyosarcoma" />
          <definitionCodeableConcept>
            <coding>
              <system value="http://snomed.info/sct" />
              <code value="302847003" />
              <display value="Rhabdomyosarcoma" />
            </coding>
          </definitionCodeableConcept>
        </characteristic>
        <characteristic>
          <description value="Age 0 - < 21 years" />
          <definitionReference>
            <reference value="Group/group-id" />
          </definitionReference>
        </characteristic>
      </EvidenceVariable>
    </resource>
  </entry>
  <entry>
    <resource>
      <Group>
        <id value="group-id" />
        <type value="person" />
        <membership value="definitional" />
        <code>
          <coding>
            <system value="http://hl7.org/fhir/CodeSystem/GroupKind" />
            <code value="cohort" />
          </coding>
        </code>
        <characteristic>
          <code>
            <coding>
              <system value="http://hl7.org/fhir/CodeSystem/GroupCharacteristicKind" />
              <code value="age-range" />
            </coding>
          </code>
          <valueRange>
            <low>
              <value value="0" />
              <unit value="year" />
            </low>
            <high>
              <value value="21" />
              <unit value="year" />
            </high>
          </valueRange>
          <exclude value="false" />
        </characteristic>
      </Group>
    </resource>
  </entry>
</Bundle>