Diagnosed or Relapsed/Refractory SarcomasNCT04621201
Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas
An observational study of Diagnosed or Relapsed/Refractory Sarcomas, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna at 10 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 years
- Conditions the study is for
- Diagnosed or Relapsed/Refractory Sarcomas
- What is being tested?
- observation and biopsy
- How many people
- 120 participants
- Where
- 10 sitesItaly
- Study dates
- 6 Dec 2018to 6 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children, adolescents and young adults aged ≤ 24 years with newly diagnosed or relapsed/refractory Osteosarcoma, Ewing Sarcoma or Synovial Sarcoma.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Celeste Cagnazzo, PhD contact
10 sites in 1 country
Italy10 sites, 8 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna
Emanuela Palmerini
- Recruiting
Policlinico S.Orsola-Malpighi
Bologna
Arcangelo Prete
- Recruiting
Azienda ospedaliero-universitaria Meyer
Florence
Angela Tamburrini
- Recruiting
Istituto Giannina Gaslini
Genova
Alberto Garaventa
- Recruiting
Istituto Nazionale Tumori
Milan
Roberto Luksch
- Suspended
Presidio Ospedaliero Gaetano Pini | ASST Pini-CTO
Milan
- Recruiting
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia
Marco Zecca
- Active, not recruiting
Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena e Istituto Dermatologico San Gallicano
Roma
- Recruiting
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
Torino, Turin, 10126
Celeste Cagnazzo, PhD, 00390113135171, celeste.cagnazzo@unito.it
- Recruiting
IRCCS materno infantile Burlo Garofolo
Trieste
Marco Rabusin
About this study
Official title: Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas (SAR-GEN_ITA): a Multicenter Prospective Study
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.
- Being tested
- observation and biopsy
- Medical subject headings
- Disease, Recurrence, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation and biopsyOther
biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2018-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start6 Dec 2018
- Primary completion6 Dec 2024 (estimated)
- Study completion6 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosed or Relapsed/Refractory SarcomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana Ematologia Oncologia Pediatrica
- Responsible party
- Principal investigator, Prof. Franca Fagioli, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
- Investigators
- Franca Fagioli, MD, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621201
- Sponsor's protocol ID
- SAR-GEN_ITA
- Status last verified
- Mar 2023
- First submitted
- 3 Nov 2020
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas (SAR-GEN_ITA): a Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT04621201
- Acronym / sponsor ID
- SAR-GEN_ITA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaUniversity, hospital or other
- Collaborators
- Associazione Italiana Ematologia Oncologia Pediatrica
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 6 Dec 2024 (estimated)
- Study completion
- 6 Dec 2026 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children, adolescents and young adults aged ≤ 24 years with newly diagnosed or relapsed/refractory Osteosarcoma, Ewing Sarcoma or Synovial Sarcoma.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observation and biopsybiopsy | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Celeste Cagnazzo, PhD contact
Franca Fagioli, MD principal investigator
A.O.U. Città della Salute e della Scienza
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnosed or Relapsed/Refractory Sarcomas, run by Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa Tirtei, MD (00390113135171, etirtei@cittadellasalute.to.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.