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

NCT04621201 | Recruiting

• 1 other identifier: SAR-GEN_ITA
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 10

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.

Conditions

Diagnosed or Relapsed/Refractory Sarcomas

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

observation and biopsy OTHER

biopsy

Eligibility Criteria

• Age: Up to 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children, adolescents and young adults aged ≤ 24 years with newly diagnosed or relapsed/refractory Osteosarcoma, Ewing Sarcoma or Synovial Sarcoma.

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna: lead
• Associazione Italiana Ematologia Oncologia Pediatrica: collaborator

Study Sites (10)

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

Torino, Turin, 10126, 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

Biospecimen

Retention: SAMPLES WITH DNA

biopsies

MeSH Terms

Conditions

Disease; Recurrence; Sarcoma

Interventions

Observation; Biopsy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Franca Fagioli, MD

  A.O.U. Città della Salute e della Scienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Tirtei, MD

CONTACT

00390113135171; etirtei@cittadellasalute.to.it

Celeste Cagnazzo, PhD

CONTACT

celeste.cagnazzo@unito.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: December 6, 2018
• Primary Completion: December 6, 2024
• Study Completion (Estimated): December 6, 2026
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10)