Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04621201 |
Recruitment Status :
Recruiting
First Posted : November 9, 2020
Last Update Posted : March 29, 2023
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Condition or disease | Intervention/treatment |
---|---|
Diagnosed or Relapsed/Refractory Sarcomas | Other: observation and biopsy |
Study Type : | Observational |
Estimated Enrollment : | 120 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas (SAR-GEN_ITA): a Multicenter Prospective Study |
Actual Study Start Date : | December 6, 2018 |
Estimated Primary Completion Date : | December 6, 2024 |
Estimated Study Completion Date : | December 6, 2026 |

- Other: observation and biopsy
biopsy
- 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 ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621201
Contact: Elisa Tirtei, MD | 00390113135171 | etirtei@cittadellasalute.to.it | |
Contact: Celeste Cagnazzo, PhD | celeste.cagnazzo@unito.it |
Italy | |
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita | Recruiting |
Torino, Turin, Italy, 10126 | |
Contact: Celeste Cagnazzo, PhD 00390113135171 celeste.cagnazzo@unito.it | |
Istituto Ortopedico Rizzoli | Recruiting |
Bologna, Italy | |
Contact: Emanuela Palmerini | |
Policlinico S.Orsola-Malpighi | Recruiting |
Bologna, Italy | |
Contact: Arcangelo Prete | |
Azienda ospedaliero-universitaria Meyer | Recruiting |
Firenze, Italy | |
Contact: Angela Tamburrini | |
Istituto Giannina Gaslini | Recruiting |
Genova, Italy | |
Contact: Alberto Garaventa | |
Istituto Nazionale Tumori | Recruiting |
Milan, Italy | |
Contact: Roberto Luksch | |
Presidio Ospedaliero Gaetano Pini | ASST Pini-CTO | Suspended |
Milan, Italy | |
Fondazione I.R.C.C.S. Policlinico San Matteo | Recruiting |
Pavia, Italy | |
Contact: Marco Zecca | |
Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena e Istituto Dermatologico San Gallicano | Active, not recruiting |
Roma, Italy | |
IRCCS materno infantile Burlo Garofolo | Recruiting |
Trieste, Italy | |
Contact: Marco Rabusin |
Principal Investigator: | Franca Fagioli, MD | AOU Città della Salute e della Scienza di Torino |
Responsible Party: | Prof. Franca Fagioli, Professor, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna |
ClinicalTrials.gov Identifier: | NCT04621201 |
Other Study ID Numbers: |
SAR-GEN_ITA |
First Posted: | November 9, 2020 Key Record Dates |
Last Update Posted: | March 29, 2023 |
Last Verified: | March 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |