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
- Diseases
- Childhood cancers, Sarcoma
- 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
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico S. Orsola Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Istituto Ortopedico Rizzoli Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Meyer Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| Istituto Nazionale Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Presidio Ospedaliero Gaetano Pini | ASST Pini-CTO Coordinator of this site? Confirm its status | Milan | Italy | Suspended |
| Fondazione I.R.C.C.S. Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena e Istituto Dermatologico San Gallicano Coordinator of this site? Confirm its status | Roma | Italy | Active, not recruiting |
| AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita Coordinator of this site? Confirm its status | Torino | Italy | Recruiting |
| IRCCS materno infantile Burlo Garofolo Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.