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

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ClinicalTrials.gov Identifier: NCT04621201
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : December 3, 2020
Sponsor:
Collaborator:
Associazione Italiana Ematologia Oncologia Pediatrica
Information provided by (Responsible Party):
Prof. Franca Fagioli, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Study Description
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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
Diagnosed or Relapsed/Refractory Sarcomas Other: observation and biopsy

Study Design
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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, 2021
Estimated Study Completion Date : December 6, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: observation and biopsy
    biopsy

Outcome Measures
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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 [ Time Frame: 2018-2021 ]

Biospecimen Retention:   Samples With DNA
biopsies

Eligibility Criteria
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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
Study Population
Children, adolescents and young adults aged ≤ 24 years with newly diagnosed or relapsed/refractory Osteosarcoma, Ewing Sarcoma or Synovial Sarcoma.
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Elisa Tirtei, MD 00390113135171 etirtei@cittadellasalute.to.it
Contact: Celeste Cagnazzo, PhD celeste.cagnazzo@unito.it

Locations
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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   
Sponsors and Collaborators
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Associazione Italiana Ematologia Oncologia Pediatrica
Investigators
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Principal Investigator: Franca Fagioli, MD AOU Città della Salute e della Scienza di Torino
More Information
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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: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms