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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorGrupo Espanol de Investigacion en Sarcomas

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Histological diagnosis of soft-tissue sarcoma, GIST or bone sarcoma (all subtypes) from January 2005 until Juny/September 2023.

≥ 18 years

Available clinical and treatment information

Disqualifiers

None

Trial population

Soft-tissue sarcoma, Gastrointestinal stromal tumor (GIST) Bone sarcoma (all subtypes)

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • Quality assessment

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

Surgical margins

using Enneking

Time frame
through study completion, an average of 3 years
2

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
3

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
4

Percentage of amputation

Resection of any member.

Time frame
through study completion, an average of 3 years

Other outcomes

Sponsors and contacts

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