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NCT04621201Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 29 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
3 Nov 2020
Start date
6 Dec 2018
Primary completion date
6 Dec 2024
Lead sponsor
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
NCT number
NCT04621201

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From 6 Dec 2018 to the primary completion date, 6 Dec 2024
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: - to 24 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Policlinico S. Orsola Malpighi
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BolognaItalyRecruiting
Istituto Ortopedico Rizzoli
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BolognaItalyRecruiting
Azienda Ospedaliero-Universitaria Meyer
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FlorenceItalyRecruiting
Istituto Giannina Gaslini
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GenovaItalyRecruiting
Istituto Nazionale Tumori
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MilanItalyRecruiting
Presidio Ospedaliero Gaetano Pini | ASST Pini-CTO
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MilanItalySuspended
Fondazione I.R.C.C.S. Policlinico San Matteo
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PaviaItalyRecruiting
Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena e Istituto Dermatologico San Gallicano
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RomaItalyActive, not recruiting
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
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TorinoItalyRecruiting
IRCCS materno infantile Burlo Garofolo
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TriesteItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.