Analyzing genomic profiles in young patients with sarcomas
Official title: Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas (SAR-GEN_ITA): a Multicenter Prospective Study
Run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna · NCT04621201 · Data updated 2026-11-12
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 |
|---|---|
| Ages | Any age to 24 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna Academic / other |
| Locations | 10 sites (Torino, Turin and 9 other locations) |
| Status | Recruiting |
| Started | December 6, 2018 |
| Main results expected | December 6, 2024 |
| Study ends | December 6, 2026 |
| Registry record updated | March 29, 2023 |
| Trial ID | NCT04621201 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies utilizing genomic profiling in pediatric cancers have shown promise, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
Show 4 more locations
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Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, Italy Recruiting -
IRCCS materno infantile Burlo Garofolo
Trieste, Italy Recruiting -
Presidio Ospedaliero Gaetano Pini | ASST Pini-CTO
Milan, Italy Suspended -
Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena e Istituto Dermatologico San Gallicano
Roma, Italy Active not recruiting
Study contacts
- Principal investigator: Franca Fagioli, MD — A.O.U. Città della Salute e della Scienza
- Study coordinator: Elisa Tirtei, MD
- Email: etirtei@cittadellasalute.to.it
- Phone: 00390113135171
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.