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

NCT04181970 | Recruiting DMC

• 1 other identifier: SELNET (GEIS 68)
• Study Type: observational
• Target: 5,000
• Locations: 8 countries
• Sites: 9

Brief 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.

Conditions

Soft-tissue Sarcoma; Gastrointestinal Stromal Tumors; Bone Sarcoma

Outcome Measures

Primary Outcomes (10)

• 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

  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

Secondary Outcomes (4)

• Surgical margins

  through study completion, an average of 3 years

• Relapse-free survival

  tthrough study completion, an average of 3 years

• Overall survival

  through study completion, an average of 3 years

• Percentage of amputation

  through study completion, an average of 3 years

Interventions

Quality assessment OTHER

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Grupo Espanol de Investigacion en Sarcomas: lead

Study Sites (9)

Alexander Fleming Sa

Buenos Aires, Argentina

NOT YET RECRUITING

A C Camargo

São Paulo, Brazil

RECRUITING

Hospital San Vicente de Paúl

Heredia, Costa Rica

NOT YET RECRUITING

Centre Leon Berard

Lyon, France

RECRUITING

Instituto Ortopedico Rizzoli

Bologna, Italy

RECRUITING

Insituto Nazionale Di Tumore

Milan, Italy

RECRUITING

Instituto Nacional de Cancerología

Mexico City, Mexico

RECRUITING

Instituo Nacional de enfermedades Neoplásicas

Surquillo, Peru

RECRUITING

Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Formalin fixed paraffin embedded tumor sample.

MeSH Terms

Conditions

Sarcoma; Gastrointestinal Stromal Tumors; Bone Neoplasms

Interventions

Quality Assurance, Health Care

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Javier MARTIN-BROTO, MD

  Salud de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Martin

CONTACT

+34 910908102; martamartinruiz@atbsarc.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 30 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: December 2, 2019
• Study Start: June 30, 2019
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1); BR (1); ES (1); ME (1); IT (2); AR (1); CO (1); FR (1)