Clinical trial NCT04621201: Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas
Official title: Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas (SAR-GEN_ITA): a Multicenter Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diagnosed or Relapsed/Refractory Sarcomas
Lead sponsor: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Sponsor class: OTHER
Collaborators: name: Associazione Italiana Ematologia Oncologia Pediatrica
First posted: 2020-11-09
Enrollment: 120
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children, adolescents and young adults aged ≤ 24 years with newly diagnosed or relapsed/refractory Osteosarcoma, Ewing Sarcoma or Synovial Sarcoma.

Brief 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 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.

Primary outcomes:
measure: evaluate the genomic profiles of osteosarcoma, Ewing sarcoma and Synovial Sarcoma tumor samples in pediatric, adolescents and young adult patients at the time of diagnosis or relapse/progression
timeFrame: 2018-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
state: Turin
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Firenze
country: Italy
facility: Azienda ospedaliero-universitaria Meyer
city: Genova
country: Italy
facility: Istituto Giannina Gaslini
city: Milan
country: Italy
facility: Istituto Nazionale Tumori
city: Milan
country: Italy
facility: Presidio Ospedaliero Gaetano Pini | ASST Pini-CTO
city: Pavia
country: Italy
facility: Fondazione I.R.C.C.S. Policlinico San Matteo
city: Roma
country: Italy
facility: Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena e Istituto Dermatologico San Gallicano
city: Trieste
country: Italy
facility: IRCCS materno infantile Burlo Garofolo
Study officials:
affiliation: A.O.U. Città della Salute e della Scienza
name: Franca Fagioli, MD
role: PRINCIPAL_INVESTIGATOR
References: