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Taking people in ItalyNo phase

Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas

Key facts

Where
Bologna, Florence, Genova, Milan, Pavia, Roma, Torino, and Trieste, ItalySee the 10 sites

Where in Italy

  • Istituto Ortopedico RizzoliBologna, ItalyTaking people
  • Policlinico S. Orsola MalpighiBologna, ItalyTaking people
  • Azienda Ospedaliero-Universitaria MeyerFlorence, ItalyTaking people
  • Istituto Giannina GasliniGenova, ItalyTaking people
  • Istituto Nazionale TumoriMilan, ItalyTaking people
  • Presidio Ospedaliero Gaetano Pini | ASST Pini-CTOMilan, ItalyNo longer taking part
  • Fondazione I.R.C.C.S. Policlinico San MatteoPavia, ItalyTaking people
  • Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena e Istituto Dermatologico San GallicanoRoma, ItalyNo longer taking part
  • AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina MargheritaTorino, ItalyTaking people
  • IRCCS materno infantile Burlo GarofoloTrieste, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Trial code
NCT04621201
Record updated
29 March 2023
Original description
Bone and soft tissue sarcomas represent about 7-12% of all pediatric cancer and are a heterogeneous group of tumors arising in connective tissues embryologically derived from the mesenchyme. For some of these tumors relapse and mortality rates are still significantly high. Therefore, further studies are needed to better understand pathogenetic processes underlying sarcomas to offer new and more effective treatments. Next generation sequencing (NGS) has opened new frontiers for cancer research allowing to identify somatic or constitutional mutations known or yet unknown with the aim to better understand carcinogenesis. The establishment of the genomic profile of the tumor could also help clinicians to personalize patients treatment based on their genetic and molecular alterations.Read full original descriptionShow less

Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas (SAR-GEN_ITA): a Multicenter Prospective Study

Bone and soft tissue sarcomas represent about 7-12% of all pediatric cancer and are a heterogeneous group of tumors arising in connective tissues embryologically derived from the mesenchyme. For some of these tumors relapse and mortality rates are still significantly high. Therefore, further studies are needed to better understand pathogenetic processes underlying sarcomas to offer new and more effective treatments. Next generation sequencing (NGS) has opened new frontiers for cancer research allowing to identify somatic or constitutional mutations known or yet unknown with the aim to better understand carcinogenesis. The establishment of the genomic profile of the tumor could also help clinicians to personalize patients treatment based on their genetic and molecular alterations.

Inclusion: Patients with histologically confirmed Osteosarcoma, Ewing Sarcoma or Synovial Sarcoma at first diagnosis; Patients with confirmed relapsed/refractory Osteosarcoma, Ewing Sarcoma or Synovial Sarcoma; Written informed consent signed by the patient, or parents or legal representative to perform molecular analysis of the tumor sample; Patients aged ≤24 years; Pathological review of tumor samples; Availability of fresh tumor sample from newly diagnosed or relapsed/refractory cancer and 10 ml of EDTA peripheral blood sample. Centralization of paraffin-embedded tumor sample might be optional.

Exclusion: 1. Known history of active HIV, HCV, or HBV infection 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient undergoing surgery biopsy or the quality of the data.

ClinicalTrials.gov NCT04621201