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

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

Recruiting
Diagnosed or Relapsed/Refractory Sarcomas

Other: observation and biopsy

biopsy

Eligibility Criteria

Inclusion Criteria:

1. Patients with histologically confirmed Osteosarcoma, Ewing Sarcoma or Synovial
Sarcoma at first diagnosis.

2. Patients with confirmed relapsed/refractory Osteosarcoma, Ewing Sarcoma or Synovial
Sarcoma

3. Written informed consent signed by the patient, or parents or legal representative
to perform molecular analysis of the tumor sample.

4. Patients aged ≤24 years

5. Pathological review of tumor samples.

6. 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 Criteria:

-

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.

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: 24 Years
Countries
Italy
Locations

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
Firenze, 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

Contacts

Elisa Tirtei, MD
00390113135171
etirtei@cittadellasalute.to.it

Celeste Cagnazzo, PhD
celeste.cagnazzo@unito.it

Franca Fagioli, MD, Principal Investigator
A.O.U. Città della Salute e della Scienza

Associazione Italiana Ematologia Oncologia Pediatrica
NCT Number
MeSH Terms
Sarcoma