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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.
Patients with an histological diagnosis of soft-tissue sarcoma, gastrointestinal stromal tumor (GIST) or bone sarcoma (all subtypes) with ≥ 18 years old are able to be included in the study.
Data registration period includes:
Retrospective part: from January 2012 until June 2019 Prospective part: from July 2019 until January 2022.
In all clinical practice guidelines, it is recommended to refer patients with suspected sarcomas to an Expert Center (EC). The pioneers in implementing EC in sarcomas have been the Scandinavian countries, where referral is mandatory. In Spain, through the Audit of the Ministry of Health, Social Affairs and Equality, 5 CSURs (Centers, Services or Reference Units). Taken together the previous information, and since the European experience in sarcoma EC and sarcoma referral policies have shown to be positive, as numerous outcome indicators favoring patients managed in EC have been reported, a European and Latin-American consortium of sarcoma centers has emerged, supported by Horizon 2020 program (Horizon 2020 Call: H2020-SC1-BHC-2018-2020) with the aim of implementing a process to facilitate the accreditation of expert centers in sarcoma as well as a network of Latin-American sarcoma centers.
A SELNET database is available for all participating countries. to register patient's clinical data: Demographic information, Type of sarcoma (Soft-tissue/Bone/GIST), Clinical presentation, Diagnosis, Treatment, and Survival and follow-up.
Quality of care will be assessed based on the analysis of different diagnostic/therapeutic items, specified in the ESMO-EURACAN clinical practice guidelines:
For the localised disease quality assessment, we'll focus on:
For advance disease quality assessment, we'll focus on:
An expert pathology review will take place to diagnose sarcoma cases and evaluate the differences in diagnosis and it outcome and consequences.
Four sarcoma subtypes have been selected to analyse further with biological tissue samples.: Angiosarcoma, Desmoplastic Small Round Cell Tumor, Extraskeletal myxoid chondrosarcoma and Solitary fibrous tumors. The aims of the translational research program are: to describe prognostic factors and/ or cell signaling pathways of relevance in AS, DSRCT, EMC and SFT; to describe predictive biomarkers of first and second line agents; to study the potential mechanisms of action of first and second line agents and their role in the activation of antitumor tumor microenvironment (e.g. immune response) and to establish preclinical models on these rare subtypes of sarcoma to validate OMICs data. This will open new doors for novel hypothesis for clinical trials based on the analysis of differential gene expression, cell signaling pathways and/ or predictive biomarkers.
Progression Free Survival (PFS), objective tumor response, Overall survival (OS), and histopathological features will be correlated with OMICs data.
Samples to collect:
All patients should sign and date the Informed Consent Form after reading the patient Information Sheet to accept participating in this study. Participating in the study is voluntary and the patient can withdraw his/her consent at any time, without giving any reason and without reducing his/her right to health care.
He/she can also withdraw the consent to use the tumor sample donated to the study without withdrawing the participation in the study (the patient's clinical data will be registered and analysed). If this happens, the tumor sample left in the central laboratory can be returned to the origin site. Any withdraw should be confirmed by signing a Revocation Form. However, the investigator should try to know the reason to withdraw consent in order to improve the study conditions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality assessment | Other | There is no intervention on study subjects. A tumor review will be performed by expert centers. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of cases with > 5 cm with tru-cut biopsies. | tumor should be bigger than 5cm | through study completion, an average of 3 years |
| Percentage of biopsies carried out by sarcoma teams vs not sarcoma team | in all the series and in cases with > 5 cm | through study completion, an average of 3 years |
| Percentage of patients with image studies at diagnosis and before surgery. | The same type of image should have been performed | through study completion, an average of 3 years |
| Percentage of patients discussed in Multidisciplinary Team before treatment | multidisciplinary team includes serval departments at the same center | through study completion, an average of 3 years |
| Percentage of patients with specified histopathological grade in pathologic report. | Using FNCLCC grade criteria | through study completion, an average of 3 years |
| Percentage of affected surgical margins in first surgery | Using Enneking classification for determinations of surgical margins | through study completion, an average of 3 years |
| Percentage of re-resections in patients with affected surgical margins in first surgery | Using Enneking classification for determinations of surgical margins |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical margins | using Enneking | through study completion, an average of 3 years |
| Relapse-free survival | days of survival from date of first line treatment until progression or death |
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Inclusion Criteria:
Exclusion Criteria:
There is no exclusion criteria
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Soft-tissue sarcoma, Gastrointestinal stromal tumor (GIST) Bone sarcoma (all subtypes)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta Martin | Contact | +34 910908102 | 52830/52832 | martamartinruiz@atbsarc.org |
| Name | Affiliation | Role |
|---|---|---|
| Javier MARTIN-BROTO, MD | Salud de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexander Fleming Sa | Not yet recruiting | Buenos Aires | Argentina |
Data could be shared receiving an application to the Study Main contact indicating reason and objectives.
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Formalin fixed paraffin embedded tumor sample.
| through study completion, an average of 3 years |
| percentage of patients with >5 cm and G2-3 sarcoma receiving neo/adjuvant radiotherapy | Using FNCLCC grade criteria | through study completion, an average of 3 years |
| Percentage of patients with localized GIST with adequate risk assessment | Classifying risk with mitotic count (50HPF), site and size of primary tumor | through study completion, an average of 3 years |
| Percentage of patients with advanced GIST with available molecular status of KIT/PDGFR before initiating systemic therapy for advanced disease | Detection of KIT/PDGFR y Sanger and or NGS | through study completion, an average of 3 years |
| tthrough study completion, an average of 3 years |
| Overall survival | Days from diagnosis (date of biopsy or first pathology report) until death whatever cause. | through study completion, an average of 3 years |
| Percentage of amputation | Resection of any member. | through study completion, an average of 3 years |
| A C Camargo | Recruiting | São Paulo | Brazil |
|
| Hospital San Vicente de Paúl | Not yet recruiting | Heredia | Costa Rica |
|
| Centre Leon Berard | Recruiting | Lyon | France |
|
| Instituto Ortopedico Rizzoli | Recruiting | Bologna | Italy |
|
| Insituto Nazionale Di Tumore | Recruiting | Milan | Italy |
|
| Instituto Nacional de Cancerología | Recruiting | Mexico City | Mexico |
|
| Instituo Nacional de enfermedades Neoplásicas | Recruiting | Surquillo | Peru |
|
| Fundación Jiménez Díaz | Recruiting | Madrid | Madrid | 28040 | Spain |
|
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D046152 | Gastrointestinal Stromal Tumors |
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009372 | Neoplasms, Connective Tissue |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D009371 | Neoplasms by Site |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D011785 | Quality Assurance, Health Care |
| ID | Term |
|---|---|
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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