Analyzing genomic profiles in young patients with sarcomas

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

This study is testing the genetic makeup of tumors in young patients with certain types of sarcomas to see if it can help create better treatment plans for those whose cancer hasn't responded to standard therapies.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: N/A to 24 Years
• Sex: All
• Sponsor: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna (Academic / other)
• Locations: 10 sites (Torino, Turin and 9 other locations)
• Trial ID: NCT04621201 on ClinicalTrials.gov

What this trial studies

This observational study focuses on children, adolescents, and young adults diagnosed with osteosarcoma, Ewing sarcoma, or synovial sarcoma. It aims to analyze the genomic profiles of these tumors using next-generation sequencing to identify mutations that could inform personalized treatment strategies. By understanding the genetic and molecular alterations in these sarcomas, the study seeks to improve treatment outcomes for patients with relapsed or refractory cases. Participants will undergo observation and biopsy to collect necessary tumor samples for analysis.

Who should consider this trial

Good fit: Ideal candidates are patients aged 24 years or younger with histologically confirmed osteosarcoma, Ewing sarcoma, or synovial sarcoma, either at first diagnosis or in a relapsed/refractory state.

Not a fit: Patients with active HIV, HCV, or HBV infections, or those with conditions that compromise safety for biopsy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment options for young patients with sarcomas.

How similar studies have performed: Other studies utilizing genomic profiling in pediatric cancers have shown promise, indicating potential for success in this approach.

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.

Where this trial is running

Torino, Turin and 9 other locations

• AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita — Torino, Turin, Italy (Recruiting)
• Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
• Policlinico S.Orsola-Malpighi — Bologna, Italy (Recruiting)
• Azienda ospedaliero-universitaria Meyer — Florence, Italy (Recruiting)
• Istituto Giannina Gaslini — Genova, Italy (Recruiting)
• Istituto Nazionale Tumori — Milan, Italy (Recruiting)
• Presidio Ospedaliero Gaetano Pini | ASST Pini-CTO — Milan, Italy (Suspended)
• Fondazione I.R.C.C.S. Policlinico San Matteo — Pavia, Italy (Recruiting)
• Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena e Istituto Dermatologico San Gallicano — Roma, Italy (Active_not_recruiting)
• IRCCS materno infantile Burlo Garofolo — Trieste, Italy (Recruiting)

Study contacts

• Principal investigator: Franca Fagioli, MD — A.O.U. Città della Salute e della Scienza
• Study coordinator: Elisa Tirtei, MD

Conditions Diagnosed or Relapsed/Refractory Sarcomas