The Italian Registry of Malnutrition in Oncology
IRMO
Multicentric, Observational, Longitudinal Study for the Evaluation of Nutritional Management Implications in Newly Diagnosed Italian Cancer Patients: The Italian Registry of Malnutrition in Oncology (IRMO)
1 other identifier
observational
1,500
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2022
CompletedFirst Submitted
Initial submission to the registry
March 21, 2024
CompletedFirst Posted
Study publicly available on registry
March 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
April 3, 2024
April 1, 2024
4.9 years
March 21, 2024
April 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
Percentage of patients who are alive.
1 year
Secondary Outcomes (2)
Progression-free survival
1 year and 2 years
Treatment toxicity
1 year
Study Arms (1)
Cohort observational
Overall study cohort
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Impossibility to undertake the expected measurements;
- Impossibility to guarantee the attendance of the follow-up visits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
IRCCS Istituto Tumori Giovanni Paolo II,
Bari, BA, Italy
IRCCS Saverio De Bellis
Castellana Grotte, BA, Italy
Istituto Ortopedico Rizzoli
Bologna, BO, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS
Meldola, FC, Italy
IRCCS Ospedale Policlinico San Martino
Genova, GE, Italy
IRCCS Ospedale San Raffaele, Milano
Milan, MI, Italy
Centro di Riferimento Oncologico
Aviano, PN, Italy
IOV Istituto Oncologico Veneto
Padua, PV, Italy
AUSL IRCCS Reggio-Emilia
Reggio Emilia, RE, Italy
IDI IRCCS - Istituto Dermopatico dell'Immacolata
Roma, RM, Italy
Istituto Nazionale Tumori Regina Elena
Roma, RM, Italy
Policlinico Universitario Agostino Gemelli
Roma, RM, Italy
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, TO, Italy
IRCCS Sacro Cuore Don Calabria
Negrar, VR, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, Italy
Fondazione IRCCS Policlinico San Matteo, Pavia
Pavia, Italy
Related Publications (3)
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.
PMID: 28710645BACKGROUNDCaccialanza 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.
PMID: 32110247BACKGROUNDPedrazzoli 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.
PMID: 32384639BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2024
First Posted
March 29, 2024
Study Start
October 25, 2022
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
April 3, 2024
Record last verified: 2024-04