The Italian Registry of Malnutrition in Oncology
- Conditions
- CancerCancer Metastatic
- Interventions
- Other: Cohort observational
- Registration Number
- NCT06337019
- Lead Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- Aged ≥18 years;
- New diagnosis of the following cancers: head and neck, oesophagus/stomach, colorectal, hepato-biliary, pancreatic, lung, prostate, other urogenital, breast, gynaecological and, soft tissue sarcomas and melanomas; patients with a new diagnosis of metastatic disease will be also included;
- Eligible for active treatment;
- Written informed consent to participate in the study.
- Impossibility to undertake the expected measurements;
- Impossibility to guarantee the attendance of the follow-up visits.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort observational Cohort observational Overall study cohort
- Primary Outcome Measures
Name Time Method Overall survival 1 year Percentage of patients who are alive.
- Secondary Outcome Measures
Name Time Method Progression-free survival 1 year and 2 years Percentage of patients who are free from tumor progression.
Treatment toxicity 1 year 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.
Trial Locations
- Locations (16)
IRCCS Istituto Tumori Giovanni Paolo II,
🇮🇹Bari, BA, Italy
Istituto Ortopedico Rizzoli
🇮🇹Bologna, BO, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS
🇮🇹Meldola, FC, Italy
IRCCS Ospedale San Raffaele, Milano
🇮🇹Milano, MI, Italy
IRCCS Saverio De Bellis
🇮🇹Castellana Grotte, BA, Italy
Centro di Riferimento Oncologico
🇮🇹Aviano, PN, Italy
IOV Istituto Oncologico Veneto
🇮🇹Padova, PV, Italy
IRCCS Ospedale Policlinico San Martino
🇮🇹Genova, GE, Italy
Policlinico Universitario Agostino Gemelli
🇮🇹Roma, RM, Italy
AUSL IRCCS Reggio-Emilia
🇮🇹Reggio Emilia, RE, Italy
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
🇮🇹Candiolo, TO, Italy
IDI IRCCS - Istituto Dermopatico dell'Immacolata
🇮🇹Roma, RM, Italy
Istituto Nazionale Tumori Regina Elena
🇮🇹Roma, RM, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
🇮🇹Napoli, Italy
IRCCS Sacro Cuore Don Calabria
🇮🇹Negrar, VR, Italy
Fondazione IRCCS Policlinico San Matteo, Pavia
🇮🇹Pavia, Italy