An observational study in Soft-tissue Sarcoma, Gastrointestinal Stromal Tumors and Bone Sarcoma, sponsored by Grupo Espanol de Investigacion en Sarcomas. Recruiting at 9 sites in 8 countries. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Grupo Espanol de Investigacion en Sarcomas · Observational
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.
1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 120 across 218 observational studies indexed under Sarcoma.
Browse Sarcoma studies →Grupo Espanol de Investigacion en Sarcomas is the lead sponsor of 20 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Soft-tissue sarcoma, Gastrointestinal stromal tumor (GIST) Bone sarcoma (all subtypes)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
There is no exclusion criteria
There is no intervention on study subjects. A tumor review will be performed by expert centers.
Percentage of cases with > 5 cm with tru-cut biopsies.
tumor should be bigger than 5cm
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 3 years
Percentage of patients with specified histopathological grade in pathologic report.
Using FNCLCC grade criteria
Time frame: through study completion, an average of 3 years
Percentage of affected surgical margins in first surgery
Using Enneking classification for determinations of surgical margins
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 3 years
Surgical margins
using Enneking
Time frame: through study completion, an average of 3 years
Relapse-free survival
days of survival from date of first line treatment until progression or death
Time frame: tthrough study completion, an average of 3 years
Overall survival
Days from diagnosis (date of biopsy or first pathology report) until death whatever cause.
Time frame: through study completion, an average of 3 years
Percentage of amputation
Resection of any member.
Time frame: through study completion, an average of 3 years
Plan to share: No — Data could be shared receiving an application to the Study Main contact indicating reason and objectives.
No publications or documents are linked to this record.
Started Jun 2019 (actual). Primary completion is estimated for Sep 2026, 87 months after the start.
Of 88 non-industry observational studies under Sarcoma, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 294. This study's planned 87 months is above that.
Counting every sponsor, half of 97 studies reached it within 66 months; a quarter within 42 and three quarters within 294.
How these figures are worked out, and which studies are left out of them.
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Grupo Espanol de Investigacion en Sarcomas