Paraganglioma/ PhaeochromocytomaPARTNERNCT07072143
An International Study on Pediatric Patients With Rare Tumors.
An observational study of Paraganglioma/ Phaeochromocytoma and Melanoma and Other Malignant Neoplasms of Skin, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial summary
The PARTNER study is an international, prospective, observational study of paediatric patients with very rare tumours. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Paraganglioma/ Phaeochromocytoma, Melanoma and Other Malignant Neoplasms of Skin, Gastrointestinal Stromal Tumor (GIST)
- How many people
- 6,250 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jan 2025to 6 Jun 2049
- Phase
- Observational
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents (0-18 years) with a primary or relapsed Very Rare Tumor (VRT)
Who may be able to join
- Children and adolescents (age 0-18 years) with a primary or relapsed Very Rare Tumor diagnosed and/or treated in a participating country/center.
- Written informed consent from the patient and/or the parent/legal guardian
Who cannot join
- Absence of Written informed consent from the patient and/or the parent/legal guardian
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Pediatric Oncology Unit, University Hospital Padova [AOUP Azienda Ospedale Università Padova]
Padova, Italy, 35127
Gianni Bisogno, Medical Doctor, 0039 0498211481, gianni.bisogno@unipd.it
Martina Bonel, Study Coordinator, 0039 049 8214413, martina.bonel@unipd.it
About this study
Official title: The PARTNER Study - An International Prospective Observational Study on Pediatric Patients With Very Rare Tumors.
The PARTNER study is an international, prospective, observational study of paediatric patients with very rare tumours.
Read the detailed description
There are some very rare tumors (with an annual incidence of less than two per million children) that can affect children and adolescents. These neoplasms include a wide variety of cancers; some are rare at any age, while others are typical of adults but very rare in children. Due to their rarity, studies have so far been scarce, often lacking univocal diagnostic criteria, and more information is needed to improve treatment outcomes.
The aim of this study is to collect epidemiological, clinical, biological, radiological and treatment data on children and adolescents with rare cancers in order to improve our understanding of these tumors and how their clinical and biological characteristics affect treatment outcomes.
Due to the rarity of these malignancies, international collaboration is necessary to collect sufficient data on each tumour type.
While the investigators are not proposing specific treatments, the data collected will inform recommendations for the diagnosis and treatment of patients.
The PARTNER Study is an observational, prospective study. It is sponsored by Padua University Hospital AOUP (Italy), and all European centres collaborating with the EXPeRT group have been invited to participate. It is a non-profit study, meaning it has no commercial purpose, only the aim of improving knowledge and treatment for children with rare cancers. PARTNER activities are supported in different countries by national funds, as well as by the European Commission through the European Reference Network for Paediatric Oncology (ERN PaedCan). Please visit https://paedcan.ern-net.eu/ for more information.
- Conditions
- Paraganglioma/ Phaeochromocytoma, Melanoma and Other Malignant Neoplasms of Skin, Gastrointestinal Stromal Tumor (GIST), Adrenocortical Tumor, Pancreatic Tumors, Esthesioneuroblastoma, Olfactory
- Keywords
- children, rare tumors, very rare tumors, adolescents, PARTNER Study
- Medical subject headings
- Melanoma, Gastrointestinal Stromal Tumors, Adrenal Cortex Neoplasms, Pancreatic Neoplasms, Esthesioneuroblastoma, Olfactory, Mesothelioma, Nasopharyngeal Carcinoma, Pleuropulmonary blastoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiology
Evaluate the number of patients (aged 0-18 years) with different Very Rare Tumors in the different countries: observed cases will be compared with expected cases.
Measured: through study completion, an average of 1 year
Use of International Recommendations
The study aims to measure the number of patients treated for different neoplasms in different countries, and the proportion of those treated in accordance with the International Recommendations.
Measured: through study completion, an average of 1 year
Survival of children and adolescents (0-18 years) affected by Very Rare Tumors
The study will correlate the clinical characteristics of the tumor (size, site, extension) with the treatment, the risk of recurrence and survival.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start25 Jan 2025
- Primary completion6 Jan 2049 (estimated)
- Study completion6 Jun 2049 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paraganglioma/ PhaeochromocytomaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 6,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Collaborators
- St. Anna Children's Hospital, Vienna, Children's Hospital Zagreb, Centre Hospitalier Universitaire de la Réunion, Klinikum Dortmund, University Children's Hospital Tuebingen, Hellenic Oncology Research Group, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Kaplan Medical Center, Rehovot, Israel, Vilnius University Hospital Santaros Klinikos, University of Skopje, Gdansk Medical University (Poland), Centro Hospitalar do Porto, Bucharest Emergency Hospital, Institute for Oncology and Radiology Serbia, Belgrade, University Hospital Bratislava, University Medical Centre Ljubljana, University of Bilbao, Göteborg University, University Hospital, Paris
- Responsible party
- Principal investigator, Gianni Bisogno, Azienda Ospedaliera di Padova
- Investigators
- Gianni Bisogno, MD, Principal investigator, Azienda Ospedale Università Padova - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072143
- Sponsor's protocol ID
- The PARTNER study (AOP3417)
- Acronym
- PARTNER
- Status last verified
- Jul 2025
- First submitted
- 15 Apr 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Orbach D, Ferrari A, Schneider DT, Reguerre Y, Godzinski J, Bien E, Stachowicz-Stencel T, Surun A, Almaraz RL, Dragomir M, Jani D, Ami TB, Roganovic J, Brecht IB, Ladenstein R, Bisogno G. The European Paediatric Rare Tumours Network - European Registry (PARTNER) project for very rare tumors in children. Pediatr Blood Cancer. 2021 Jun;68 Suppl 4:e29072. doi: 10.1002/pbc.29072. Epub 2021 Apr 29.
PubMed 33913610