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

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.

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Key information

Conditions

Diagnosed or Relapsed/Refractory Sarcomas Disease Disease Attributes Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Sarcoma

Age range

Up to 24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation and biopsy

Other

biopsy

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Celeste Cagnazzo, PhD

CONTACT

[email protected]

Elisa Tirtei, MD

CONTACT

[email protected]

00390113135171

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Other

Collaborators

Associazione Italiana Ematologia Oncologia Pediatrica

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2026
First posted: Nov 9, 2020
Registry last updated: Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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