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Recruiting NCT07072143

An International Study on Pediatric Patients With Rare Tumors.

— Observational Paraganglioma/ Phaeochromocytoma Melanoma and Other Malignant Neoplasms of Skin Gastrointestinal Stromal Tumor (GIST) Adrenocortical Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Paraganglioma/ Phaeochromocytoma, Melanoma and Other Malignant Neoplasms of Skin, Gastrointestinal Stromal Tumor (GIST), Adrenocortical Tumor. Basic parameters: 0 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The PARTNER Study - An International Prospective Observational Study on Pediatric Patients With Very Rare Tumors.

Overview

The PARTNER study is an international, prospective, observational study of paediatric patients with very rare tumours.

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.

Primary outcome measures

  • Epidemiology [Time frame: through study completion, an average of 1 year]
  • Use of International Recommendations [Time frame: through study completion, an average of 1 year]
  • Survival of children and adolescents (0-18 years) affected by Very Rare Tumors [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Absence of Written informed consent from the patient and/or the parent/legal guardian

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 1 center
  • Pediatric Oncology Unit, University Hospital Padova [AOUP Azienda Ospedale Università Pado — Padova

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. PMID 33913610

Identifiers

NCT: NCT07072143 · The PARTNER study (AOP3417)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗