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

Sponsor
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna (Other)
Overall Status
Recruiting
CT.gov ID
NCT04621201
Collaborator
Associazione Italiana Ematologia Oncologia Pediatrica (Other)
120
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96
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: observation and biopsy

Study Design

Study Type:
Observational
Anticipated 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 :
Dec 6, 2018
Anticipated Primary Completion Date :
Dec 6, 2024
Anticipated Study Completion Date :
Dec 6, 2026

Outcome Measures

Primary Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita Torino Turin Italy 10126
2 Istituto Ortopedico Rizzoli Bologna Italy
3 Policlinico S.Orsola-Malpighi Bologna Italy
4 Azienda ospedaliero-universitaria Meyer Firenze Italy
5 Istituto Giannina Gaslini Genova Italy
6 Istituto Nazionale Tumori Milan Italy
7 Presidio Ospedaliero Gaetano Pini | ASST Pini-CTO Milan Italy
8 Fondazione I.R.C.C.S. Policlinico San Matteo Pavia Italy
9 Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena e Istituto Dermatologico San Gallicano Roma Italy
10 IRCCS materno infantile Burlo Garofolo Trieste Italy

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Franca Fagioli, MD, AOU Città della Salute e della Scienza di Torino

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Nov 9, 2020
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022