RecruitingNCT04621201

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

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


Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Enrollment

120 participants

Start Date

Dec 6, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Max Age: 24 Years

Inclusion Criteria6

  • 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 Criteria1

  • \. 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.

Interventions

OTHERobservation and biopsy

biopsy


Locations(10)

AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita

Torino, Turin, Italy

Istituto Ortopedico Rizzoli

Bologna, Italy

Policlinico S.Orsola-Malpighi

Bologna, Italy

Azienda ospedaliero-universitaria Meyer

Florence, Italy

Istituto Giannina Gaslini

Genova, Italy

Istituto Nazionale Tumori

Milan, Italy

Presidio Ospedaliero Gaetano Pini | ASST Pini-CTO

Milan, Italy

Fondazione I.R.C.C.S. Policlinico San Matteo

Pavia, Italy

Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena e Istituto Dermatologico San Gallicano

Roma, Italy

IRCCS materno infantile Burlo Garofolo

Trieste, Italy

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NCT04621201