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| Name | Class |
|---|---|
| Istituto Di Ricerche Farmacologiche Mario Negri | OTHER |
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The aim of the Italian Registry of Malnutrition in Oncology (IRMO) is to set up a digital register of newly diagnosed or treated oncologic patients to monitor their nutritional status, early identify malnutrition and investigate the implications of nutritional support management. In particular, this project aims to establish a prospective cohort of cancer patients in order to investigate the effects of nutritional status and management on overall survival (OS) and progression free survival (PFS), and analyse the effects of the nutritional management and support on patients' symptoms and QoL.
This is a multicentric longitudinal observational study on a cohort of newly diagnosed cancer patients, candidate for active treatment. In Italy, no reliable data are still available with regards to the actual implementation of adequate nutritional support management in cancer patients; only "real-world" data collected by administrative databases are available in the context of nutrition in oncology, and this somehow limits the possibility to interpret the evidence from a clinical point of view. Hence, the purpose of the intestigators is to collect "real world" clinical data on malnutrition in oncology at the national level, in order to strengthen the evidence and concretely improve nutritional care practices in oncology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort observational | Overall study cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort observational | Other | Cohort observational |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Percentage of patients who are alive. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Percentage of patients who are free from tumor progression. | 1 year and 2 years |
| Treatment toxicity | Treatment-related severe adverse event (grade > or =3) according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) and toxicity resulting in any treatment delay or dose reduction. |
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Inclusion Criteria:
Exclusion Criteria:
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Newly diagnosed adult cancer patients, candidate for active treatment consecutively identified in 12 Italian IRCCS members of the ACC WG "Survivorship Care e Supporto Nutrizionale". Identification of consecutive cancer patients can be done over two weeks a month only, for the centres with the higher patients' load.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Riccardo Caccialanza | Contact | +39 0382501615 | r.caccialanza@smatteo.pv.it | |
| Cristina Bosetti | Contact | cristina.bosetti@marionegri.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Tumori Giovanni Paolo II, | Not yet recruiting | Bari | BA | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28710645 | Background | Caccialanza R, De Lorenzo F, Gianotti L, Zagonel V, Gavazzi C, Farina G, Cotogni P, Cinieri S, Cereda E, Marchetti P, Nardi M, Iannelli E, Santangelo C, Traclo F, Pinto C, Pedrazzoli P. Nutritional support for cancer patients: still a neglected right? Support Care Cancer. 2017 Oct;25(10):3001-3004. doi: 10.1007/s00520-017-3826-1. Epub 2017 Jul 14. No abstract available. | |
| 32110247 |
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Data derived from the study are property of the Promoter, who will commit to sharing them with the Investigators of each participating centres and to publish the results of the study in order to give full and timely information to the scientific community. The results of the research could be communicated to third parties and made public in conferences by the Investigators after accordance with the Study Responsible, in compliance with the Ministerial Decree of 2.05.2006.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1 year |
| IRCCS Saverio De Bellis | Recruiting | Castellana Grotte | BA | Italy |
|
| Istituto Ortopedico Rizzoli | Recruiting | Bologna | BO | Italy |
|
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS | Recruiting | Meldola | FC | Italy |
|
| IRCCS Ospedale Policlinico San Martino | Not yet recruiting | Genova | GE | Italy |
|
| IRCCS Ospedale San Raffaele, Milano | Recruiting | Milan | MI | Italy |
|
| Centro di Riferimento Oncologico | Recruiting | Aviano | PN | Italy |
|
| IOV Istituto Oncologico Veneto | Recruiting | Padova | PV | Italy |
|
| AUSL IRCCS Reggio-Emilia | Recruiting | Reggio Emilia | RE | Italy |
|
| IDI IRCCS - Istituto Dermopatico dell'Immacolata | Recruiting | Roma | RM | Italy |
|
| Istituto Nazionale Tumori Regina Elena | Recruiting | Roma | RM | Italy |
|
| Policlinico Universitario Agostino Gemelli | Recruiting | Roma | RM | Italy |
|
| Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS | Recruiting | Candiolo | TO | Italy |
|
| IRCCS Sacro Cuore Don Calabria | Recruiting | Negrar | VR | Italy |
|
| Istituto Nazionale Tumori IRCCS Fondazione G. Pascale | Not yet recruiting | Naples | Italy |
|
| Fondazione IRCCS Policlinico San Matteo, Pavia | Recruiting | Pavia | Italy |
|
| Background |
| Caccialanza R, Goldwasser F, Marschal O, Ottery F, Schiefke I, Tilleul P, Zalcman G, Pedrazzoli P. Unmet needs in clinical nutrition in oncology: a multinational analysis of real-world evidence. Ther Adv Med Oncol. 2020 Feb 14;12:1758835919899852. doi: 10.1177/1758835919899852. eCollection 2020. |
| 32384639 | Background | Pedrazzoli P, Caccialanza R, Cotogni P, Degli Esposti L, Perrone V, Sangiorgi D, Di Costanzo F, Gavazzi C, Santoro A, Pinto C. The Advantages of Clinical Nutrition Use in Oncologic Patients in Italy: Real World Insights. Healthcare (Basel). 2020 May 6;8(2):125. doi: 10.3390/healthcare8020125. |