An International Study on Pediatric Patients With Rare Tumors.

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	0 Years - 18 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07072143
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Azienda Ospedaliera di Padova
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Gianni Bisogno, MD
Principal Investigator Affiliation	Azienda Ospedale Università Padova - Italy
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Paraganglioma/ Phaeochromocytoma, Melanoma and Other Malignant Neoplasms of Skin, Gastrointestinal Stromal Tumor (GIST), Adrenocortical Tumor, Pancreatic Tumors, Esthesioneuroblastoma, Olfactory, Mesothelioma, Nasopharyngeal Carcinoma (NPC), NUT Carcinoma, Pleuropulmonary Blastoma, Salivary Gland Tumors, Thymic Tumors, Thyroid Carcinoma, Appendiceal Cancers
Study Website:	View Trial Website

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Padua 3171728, Italy, Italy

Status

Recruiting

Address

Pediatric Oncology Unit, University Hospital Padova [AOUP Azienda Ospedale Università Padova]

Padua 3171728, Italy, 35127

Site Contact

Gianni Bisogno, Medical Doctor

[email protected]

0039 0498211481

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