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Bundle [documentation R4 R5 R6]
id: clinical-trial-document-id
Type: document
Timestamp: 2021-02-01 Time: 10:10:10Z
Composition [documentation R4 R5 R6]
id: (none)
fullUrl: urn:uuid:1195d0c6-2db9-4017-8ae3-c8a90137e83d
Type: Clinical Trial [100000072064] (https://spor.ema.europa.eu/v1/lists/100000072055)
Date: 2021-02-01
Status: final
Title: A Protocol for Non Metastatic Rhabdomyosarcoma
Author
Identifier: LOC-10009999 (http://spor.ema.europa.eu/v1/locations)
Section
Title: 1. PROTOCOL SPONSOR
Code: Protocol Sponsor [00000021211] (http://spor.ema.europa.eu/v1/example-sections)
Text
Status: additional
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.
Section
Title: 2. Protocol Co-ordination
Code: Protocol Co-ordination [00000021212] (http://spor.ema.europa.eu/v1/example-sections)
Text
Status: additional

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

  • The Co-operative Weichteilsarkom Studie (CWS)
  • The AIEOP Soft Tissue Sarcoma Committee (AIEOP STSC)
    (former ICG: Italian Cooperative Group for paediatric soft tissue sarcoma)
  • The SIOP Malignant Mesenchymal Tumour Committee (SIOP MMT)

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.

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.

Section
Title: 6. Summary
Code: Summary [0000002223336] (http://spor.ema.europa.eu/v1/example-sections)
Text
Status: additional

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.

Section
Title: PATIENTS ELIGIBILITY
Code: Eligibility [0000005557] (http://spor.ema.europa.eu/v1/example-sections)
Text
Status: additional

A) To the observational study

  • Patients with pathologically confirmed rhabdomyosarcoma
  • No evidence of metastatic disease
  • Age 0 - < 21 years
Subject
Found a parent (Composition/subject, id: (none) fullUrl: urn:uuid:1195d0c6-2db9-4017-8ae3-c8a90137e83d)
which is linked to this by resource.id
Research Study [documentation R4 R5 R6]
id: study-id
fullUrl: urn:uuid:812a430c-0eda-4615-a30b-a760edaa3597
Title: A Protocol for Non Metastatic Rhabdomyosarcoma
Identifier: RMS2005 (https://eudract.europa.eu/example/identifier)
Status: active
Summary: 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)
Condition: Rhabdomyosarcoma [302847003] (http://snomed.info/sct)
Associated Party
Name: The Co-operative Weichteilsarkom Studie (CWS)
Role: Collaborator [collaborator] (http://hl7.org/fhir/CodeSystem/ResearchStudyPartyRole)
Name: The AIEOP Soft Tissue Sarcoma Committee (AIEOP STSC)
Role: Collaborator [collaborator] (http://hl7.org/fhir/CodeSystem/ResearchStudyPartyRole)
Name: The SIOP Malignant Mesenchymal Tumour Committee (SIOP MMT)
Role: Collaborator [collaborator] (http://hl7.org/fhir/CodeSystem/ResearchStudyPartyRole)
Recruitment
Eligibility Criteria (EvidenceVariable) [documentation R4 R5 R6]
id: evidence-variable
fullUrl: (none)
Title: Patients for Rhabdomyosarcoma Study
Status: active
Characteristic
Description: Patients with pathologically confirmed rhabdomyosarcoma
Definition code: Rhabdomyosarcoma [302847003] (http://snomed.info/sct)
Characteristic
Description: Age 0 - < 21 years
Group [documentation R4 R5 R6]
id: group-id
fullUrl: (none)
Type: person
Code: cohort (http://hl7.org/fhir/CodeSystem/GroupKind)
Membership: definitional
Characteristic
Code: age-range (http://hl7.org/fhir/CodeSystem/GroupCharacteristicKind)
Low: 0 year
High: 21 year