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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04181970
Recruitment Status : Recruiting
First Posted : December 2, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol de Investigacion en Sarcomas

Study Description
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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.


Condition or disease Intervention/treatment
Soft-tissue Sarcoma Gastrointestinal Stromal Tumors Bone Sarcoma Other: Quality assessment

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Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 30 Months
Official 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
Actual Study Start Date : June 30, 2019
Estimated Primary Completion Date : January 30, 2022
Estimated Study Completion Date : January 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Quality assessment
    There is no intervention on study subjects. A tumor review will be performed by expert centers.

Outcome Measures
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Primary Outcome Measures :
  1. Percentage of cases with > 5 cm with tru-cut biopsies. [ Time Frame: through study completion, an average of 3 years ]
    tumor should be bigger than 5cm

  2. Percentage of biopsies carried out by sarcoma teams vs not sarcoma team [ Time Frame: through study completion, an average of 3 years ]
    in all the series and in cases with > 5 cm

  3. Percentage of patients with image studies at diagnosis and before surgery. [ Time Frame: through study completion, an average of 3 years ]
    The same type of image should have been performed

  4. Percentage of patients discussed in Multidisciplinary Team before treatment [ Time Frame: through study completion, an average of 3 years ]
    multidisciplinary team includes serval departments at the same center

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

  6. Percentage of affected surgical margins in first surgery [ Time Frame: through study completion, an average of 3 years ]
    Using Enneking classification for determinations of surgical margins

  7. Percentage of re-resections in patients with affected surgical margins in first surgery [ Time Frame: through study completion, an average of 3 years ]
    Using Enneking classification for determinations of surgical margins

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

  9. Percentage of patients with localized GIST with adequate risk assessment [ Time Frame: through study completion, an average of 3 years ]
    Classifying risk with mitotic count (50HPF), site and size of primary tumor

  10. 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 ]
    Detection of KIT/PDGFR y Sanger and or NGS


Secondary Outcome Measures :
  1. Surgical margins [ Time Frame: through study completion, an average of 3 years ]
    using Enneking

  2. Relapse-free survival [ Time Frame: tthrough study completion, an average of 3 years ]
    days of survival from date of first line treatment until progression or death

  3. Overall survival [ Time Frame: through study completion, an average of 3 years ]
    Days from diagnosis (date of biopsy or first pathology report) until death whatever cause.

  4. Percentage of amputation [ Time Frame: through study completion, an average of 3 years ]
    Resection of any member.


Biospecimen Retention:   Samples With DNA
Formalin fixed paraffin embedded tumor sample.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Soft-tissue sarcoma, Gastrointestinal stromal tumor (GIST) Bone sarcoma (all subtypes)
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181970


Contacts
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Contact: Sofía Rubio +34 955923113 srubio@selnet-h2020.org

Locations
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Argentina
Alexander Fleming Sa Not yet recruiting
Buenos Aires, Argentina
Contact: Matías Chacón, MD       matiemi@yahoo.com   
Brazil
A C Camargo Not yet recruiting
São Paulo, Brazil
Contact: Celso Mello, MD       celso.almello@gmail.com   
Costa Rica
Hospital San Vicente de Paúl Not yet recruiting
Heredia, Costa Rica
Contact: Natalia Jimenez, MD       najime22@gmail.com   
France
Centre Leon Berard Not yet recruiting
Lyon, France
Contact: Jean Y Blay, Prof MD       jean-yves.blay@lyon.unicancer.fr   
Italy
Instituto Ortopedico Rizzoli Not yet recruiting
Bologna, Italy
Contact: Alberto Righi, MD       alberto.righi@ior.it   
Contact: Martina Piccini, MD       martina.piccinnileopardi@ior.it   
Insituto Nazionale Di Tumore Not yet recruiting
Milan, Italy
Contact: Paolo Casali, MD       paolo.casali@istitutotumori.mi.it   
Contact: Bruna David, MD       bbld@globo.com   
Mexico
Instituto Nacional de Cancerología Not yet recruiting
Mexico City, Mexico
Contact: Jorge L Martínez Tlahuel, MD       dr.jorgetlahuel@gmail.com   
Contact: Jorge Vikes, MD       jorge_vikes@hotmail.com   
Peru
Instituo Nacional de enfermedades Neoplásicas Not yet recruiting
Surquillo, Peru
Contact: Victor Castro Oliden, MD       vcastrooliden@gmail.com   
Spain
Hospital Virgen del Rocío Recruiting
Seville, Andalucía, Spain, 41013
Contact: Javier MARTIN-BROTO, MD       jmartin@mustbesevilla.org   
Contact: Nadia Hindi Muñiz, MD       nhindi@mustbesevilla.org   
Sponsors and Collaborators
Grupo Espanol de Investigacion en Sarcomas
Investigators
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Principal Investigator: Javier MARTIN-BROTO, MD Andaluz Health Service
More Information
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Responsible Party: Grupo Espanol de Investigacion en Sarcomas
ClinicalTrials.gov Identifier: NCT04181970    
Other Study ID Numbers: SELNET (GEIS 68)
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data could be shared receiving an application to the Study Main contact indicating reason and objectives.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Gastrointestinal Stromal Tumors
Osteosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Connective Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms, Bone Tissue