Observational Study, for Quality Assessment, of Sarcoma in European and Latin American Multidisciplinary NETWORK

Condition(s) studied

Investigational drug(s) / intervention(s)

Quality assessment: There is no intervention on study subjects. A tumor review will be performed by expert centers.

Study summary

Post-authorisation, multicentric, observational, retrospective and prospective study to assess quality of care of sarcoma patients in expert and non-expert centers by analysing correlation of quality items and outcomes such as relapse free survival, overall survival, percentage of amputation, etc.

Expert pathology peer review will be performed to detect differences between expert and non-expert centers as well as differences in treatment and patient prognosis.

Tumor samples of 4 types of sarcoma would also be included in translational research to detect biomarkers and produce preclinical models.

Eligibility

Primary outcome measure(s)

• Percentage of cases with > 5 cm with tru-cut biopsies. — through study completion, an average of 3 years
  tumor should be bigger than 5cm
• Percentage of biopsies carried out by sarcoma teams vs not sarcoma team — through study completion, an average of 3 years
  in all the series and in cases with \> 5 cm
• Percentage of patients with image studies at diagnosis and before surgery. — through study completion, an average of 3 years
  The same type of image should have been performed
• Percentage of patients discussed in Multidisciplinary Team before treatment — through study completion, an average of 3 years
  multidisciplinary team includes serval departments at the same center
• Percentage of patients with specified histopathological grade in pathologic report. — through study completion, an average of 3 years
  Using FNCLCC grade criteria
• Percentage of affected surgical margins in first surgery — through study completion, an average of 3 years
  Using Enneking classification for determinations of surgical margins
• Percentage of re-resections in patients with affected surgical margins in first surgery — through study completion, an average of 3 years
  Using Enneking classification for determinations of surgical margins
• percentage of patients with >5 cm and G2-3 sarcoma receiving neo/adjuvant radiotherapy — through study completion, an average of 3 years
  Using FNCLCC grade criteria
• Percentage of patients with localized GIST with adequate risk assessment — through study completion, an average of 3 years
  Classifying risk with mitotic count (50HPF), site and size of primary tumor
• Percentage of patients with advanced GIST with available molecular status of KIT/PDGFR before initiating systemic therapy for advanced disease — through study completion, an average of 3 years
  Detection of KIT/PDGFR y Sanger and or NGS

Trial sites (9)

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