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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 February 2021
• Main ID: NCT04181970
• Date of registration: 27/06/2019
• Prospective Registration: Yes
• Primary sponsor: Grupo Espanol de Investigacion en Sarcomas
• Public title: Observational Study, for Quality Assessment, of Sarcoma in European and Latin American Multidisciplinary NETWORK (SELNET)
• Scientific title: Observational Study, for Quality Assessment, of Sarcoma as a Model to Improve Diagnosis and Clinical Care of Rare Tumors Through a European and Latin American Multidisciplinary NETWORK
• Date of first enrolment: June 30, 2019
• Target sample size: 5000
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04181970
• Study type: Observational [Patient Registry]

Countries of recruitment

Argentina, Brazil, Costa Rica, France, Italy, Mexico, Peru, Spain

Contacts

• Name: Sofía Rubio

• Name: Javier MARTIN-BROTO, MD
• Affiliation: Andaluz Health Service

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histological diagnosis of soft-tissue sarcoma, GIST or bone sarcoma (all subtypes)
from January 2012 until January 2022.

- = 18 years

- Available clinical and treatment information

Exclusion Criteria:

There is no exclusion criteria



Age minimum: 18 Years
Age maximum: 120 Years
Gender: All

Health Condition(s) or Problem(s) studied

Bone Sarcoma

Gastrointestinal Stromal Tumors

Soft-tissue Sarcoma

Intervention(s)

Other: Quality assessment

Primary Outcome(s)

Percentage of affected surgical margins in first surgery [Time Frame: through study completion, an average of 3 years]

Percentage of biopsies carried out by sarcoma teams vs not sarcoma team [Time Frame: through study completion, an average of 3 years]

Percentage of cases with > 5 cm with tru-cut biopsies. [Time Frame: through study completion, an average of 3 years]

Percentage of patients discussed in Multidisciplinary Team before treatment [Time Frame: through study completion, an average of 3 years]

percentage of patients with >5 cm and G2-3 sarcoma receiving neo/adjuvant radiotherapy [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 [Time Frame: through study completion, an average of 3 years]

Percentage of patients with image studies at diagnosis and before surgery. [Time Frame: through study completion, an average of 3 years]

Percentage of patients with localized GIST with adequate risk assessment [Time Frame: through study completion, an average of 3 years]

Percentage of patients with specified histopathological grade in pathologic report. [Time Frame: through study completion, an average of 3 years]

Percentage of re-resections in patients with affected surgical margins in first surgery [Time Frame: through study completion, an average of 3 years]

Secondary Outcome(s)

Overall survival [Time Frame: through study completion, an average of 3 years]

Percentage of amputation [Time Frame: through study completion, an average of 3 years]

Relapse-free survival [Time Frame: tthrough study completion, an average of 3 years]

Surgical margins [Time Frame: through study completion, an average of 3 years]

Secondary ID(s)

SELNET (GEIS 68)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors