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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04621201
Enrollment
120
Registered
2020-11-09
Start date
2018-12-06
Completion date
2026-12-06
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosed or Relapsed/Refractory Sarcomas

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.

Interventions

OTHERobservation and biopsy

biopsy

Sponsors

Associazione Italiana Ematologia Oncologia Pediatrica
CollaboratorOTHER
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 24 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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/progression2018-2021

Countries

Italy

Contacts

Primary ContactElisa Tirtei, MD
etirtei@cittadellasalute.to.it00390113135171
Backup ContactCeleste Cagnazzo, PhD
celeste.cagnazzo@unito.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026