Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: observation and biopsy.
- Who it may be relevant to
- Registry conditions: Diagnosed or Relapsed/Refractory Sarcomas. Basic parameters: up to 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas (SAR-GEN_ITA): a Multicenter Prospective Study
Overview
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.
Interventions
- Other observation and biopsy
biopsy
Primary outcome measures
- 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 [Time frame: 2018-2021]
Eligibility criteria
Inclusion criteria
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 10 centers
- AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita — Torino
- Istituto Ortopedico Rizzoli — Bologna
- Policlinico S.Orsola-Malpighi — Bologna
- Azienda ospedaliero-universitaria Meyer — Florence
- Istituto Giannina Gaslini — Genova
- Istituto Nazionale Tumori — Milan
- Presidio Ospedaliero Gaetano Pini | ASST Pini-CTO — Milan
- Fondazione I.R.C.C.S. Policlinico San Matteo — Pavia
- … and 2 more centers
Identifiers
NCT: NCT04621201 · SAR-GEN_ITA