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

Recruiting

• Conditions: Diagnosed or Relapsed/Refractory Sarcomas

• Registration Number: NCT04621201
• Lead Sponsor: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-06
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29
• Primary Completion: 2024-12-06
• Study Completion: 2026-12-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	2018-2021

Trial Locations

Locations (10)

Azienda ospedaliero-universitaria Meyer; 🇮🇹 Firenze, Italy

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy

AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita; 🇮🇹 Torino, Turin, Italy

Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, Italy

IRCCS materno infantile Burlo Garofolo; 🇮🇹 Trieste, Italy

Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena e Istituto Dermatologico San Gallicano; 🇮🇹 Roma, 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