PD-1 Blockade Combined With Definitive Chemoradiation in Locoregionally-advanced Nasopharyngeal...
Nasopharyngeal NeoplasmsThis trial plans to enroll 40 patients with stage III-IVA (AJCC 8th, except T3N0-1 or T4N0) locoregionally-advanced nasopharyngeal carcinoma (NPC). Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation. All patients will receive intensity-modulated radiotherapy (IMRT). Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 6 cycles.
Toripalimab Combined With Chemoradiotherapy in Patients With Locoregionally-advanced Nasopharyngeal...
Nasopharyngeal NeoplasmsThis is an open-label, parallel controlled, phase IIa exploratory study that evaluates the efficacy and safety of Toripalimab (PD-1 Antibody) combined with induction chemotherapy (Albumin-bound paclitaxel and cisplatin )and concurrent chemoradiotherapy in the treatment of nasopharyngeal carcinoma and explores the biomarkers that can predict the efficacy and toxicity of the treatment.
Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic...
Chronic Rhinosinusitis With Nasal PolyposisThe primary objectives of the study are: To longitudinally characterize the long-term effectiveness of DUPIXENT® through assessment of patient-reported symptoms, Health-Related Quality of Life (HRQoL) related to Chronic rhinosinusitis with nasal polyposis (CRSwNP) and other type 2 comorbidities, and their change over-time. To characterize patients who receive DUPIXENT® for CRSwNP in a real-world setting with respect to their medical history, demographic and disease characteristics, and type 2 comorbidities The secondary objectives of the study are: To characterize real-world utilization of DUPIXENT® for patients with CRSwNP To collect patient and physician global assessment of disease severity and treatment satisfaction for patients receiving DUPIXENT® for CRSwNP To collect long-term safety data for patients receiving DUPIXENT® for CRSwNP
A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients...
Familial Adenomatous PolyposisThe purpose of this study is to determine the efficacy and safety of a personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients with familial adenomatous polyposis (FAP)
A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis...
Familial Adenomatous PolyposisThe purpose of this study is to determine the efficacy and safety of a personalised surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) that have undergone (procto)colectomy.
Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients
Nasopharyngeal CancerProstate Cancer1 morePatients with cancers that are sensitive to radiotherapy treatment and/or patients who have experienced severe acute/ late side effects to radiotherapy will be recruited to the study. Blood and/or matched tumour-normal tissue pairs will be collected. Blood and/or tissue samples will be processed and studied for genetic and biochemical markers that have potential to be used for predicting sensitivity to radiation.
A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases...
Essential HypertensionLiver Cancer9 moreThe human gut microbiome has been associated with many health factors but variability between studies limits the exploration of effects between them. This study aims to systematically characterize the gut microbiota of various critical chronic diseases, compare the similarities and differences of the microbiome signatures linked to different regions and diseases, and further investigate their impacts on microbiota-based diagnostic models.
The Head and Neck Registry of the European Reference Network on Rare Adult Solid Cancers
Head and Neck CancerNasopharynx Cancer3 moreCancer care for head and neck cancers is multidisciplinary and complex and knowledge on the rare ones is limited. There is a wide consensus that to support clinical research on rare cancers, clinical registries should be developed within networks specializing in rare cancers. Our hypothesis is that our head and neck cancer registry established in the framework of the European reference network on rare adults solid cancers will help to: describe the natural history of rare head and neck cancers; evaluate factors that influence prognosis; assess treatment effectiveness; measure indicators of quality of care. The registry is a prospective observational real-world registry. It collects data from already available registries/database and/or directly from expert health care providers (HCP). Information are prospectively collected on patient characteristics; exposure, outcomes and potential confounders (https://euracan.eu/research/starter/rare-head-and-neck-cancer-registry/#codebook). The registry if federated (i.e. data are stored by the data provider). Analyses will be performed using the federated learning approach which split computations into a local part and a central part. The data providers will share sub-computations only. Data quality checks are envisioned to assess whether data value are present, valid and believable. Validity and plausibility checks are embedded in the electronic case report form (CRF) in the form of alerts and errors during the data input. Additional checks are implemented in R and run using the federated learning to ensure a central data quality monitoring. The data analyses will include descriptive statistics showing frequency and patterns of patients' and cancers' variables; analytical analyses investigating the association of patients/disease and/or treatment characteristics and health outcomes. Fondazione IRCCS Istituto Nazionale dei Tumori (INT) is the coordinator of the EURACAN registry as well as a data provider. At the INT, and at each HCP involved, responsible investigators ensure that the EURACAN registry will be implemented in compliance with the protocol, following the instructions and procedures described herein. Each HCP is a controller and will identify a data processor. The processing of patients' personal data taking part in the registry is compliant with local privacy legislation and the General Data Protection Regulation 2016/679 of the EU.
Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis
Familial Adenomatous PolyposisThe purpose of this study is to collect prospective observational data regarding patients with diagnosed Familial Adenomatous Polyposis (FAP) undergoing cold snare polypectomy for duodenal adenomas
Development of a Severity Assessment Score for Nasosinus Polyposis (PSI Score)
Nasal Polyposisnasosinus polyposis (=PNS) is a chronic inflammatory disease of the nasal cavity and sinus cavity with a prevalence of 2 to 4% in the general population. The functional impact of PNS has a major impact on one's quality of life.Medical treatment, nasal irrigations and local glucocorticoids as well as short treatment of oral glucocorticoids have shown a short-term benefit versus placebo. Surgery improves the efficacy of local treatments, but 40% of patients have a recurrence of polyps at 18 months and 20% of patients require a surgery recovery at 5 years. The development of monoclonal antibodies directly targeting the inflammatory way is a real public health issue. Bachert C. et al recently demonstrated the efficacy of Dupilumab (anti-IL-4/13 antibody) injected subcutaneously on the overall symptomatology of PNS. The marketing authorization (AMM) for the first biotherapy to be available soon includes PNS's severe nature and resistance to treatment, although there is no consensus definition or score to characterize this severity. This study aims at developping a score for assessing severity in PNS. We suggest that this assessment strategy could be applied to the PNS. The originality and the innovative character of this project is the statistical modeling behind the creation of the score. Thus, the importance of symptoms, anatomical and biological factors, the estimation of the quality of life of the patients, the level of care use and the number of surgeries all become measurable indicators that are a direct reflexion of the severity and the control of PNS, called latent variables because they cannot be directly measured. To consider this detail, modeling using structural equations seems optimal to develop a severity score (PSI score) of PNS in order to personalize the therapeutic care of patients. Main Objective: To develop a severity score for PNS using latent variable modeling: Polyps Severity Index (PSI)