The Italian Registry of Malnutrition in Oncology

NCT ID: NCT06337019

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-25
• Study Completion Date: 2027-10-31

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.

Conditions

Cancer; Cancer Metastatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort observational

Overall study cohort

Cohort observational

Intervention Type: OTHER

Cohort observational

Interventions

Cohort observational

Cohort observational

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Impossibility to undertake the expected measurements;
• Impossibility to guarantee the attendance of the follow-up visits.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Di Ricerche Farmacologiche Mario Negri

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Istituto Tumori Giovanni Paolo II,

Bari, BA, Italy

Site Status: NOT_YET_RECRUITING

IRCCS Saverio De Bellis

Castellana Grotte, BA, Italy

Site Status: RECRUITING

Istituto Ortopedico Rizzoli

Bologna, BO, Italy

Site Status: RECRUITING

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS

Meldola, FC, Italy

Site Status: RECRUITING

IRCCS Ospedale Policlinico San Martino

Genova, GE, Italy

Site Status: NOT_YET_RECRUITING

IRCCS Ospedale San Raffaele, Milano

Milan, MI, Italy

Site Status: RECRUITING

Centro di Riferimento Oncologico

Aviano, PN, Italy

Site Status: RECRUITING

IOV Istituto Oncologico Veneto

Padua, PV, Italy

Site Status: RECRUITING

AUSL IRCCS Reggio-Emilia

Reggio Emilia, RE, Italy

Site Status: RECRUITING

IDI IRCCS - Istituto Dermopatico dell'Immacolata

Roma, RM, Italy

Site Status: RECRUITING

Istituto Nazionale Tumori Regina Elena

Roma, RM, Italy

Site Status: RECRUITING

Policlinico Universitario Agostino Gemelli

Roma, RM, Italy

Site Status: RECRUITING

Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS

Candiolo, TO, Italy

Site Status: RECRUITING

IRCCS Sacro Cuore Don Calabria

Negrar, VR, Italy

Site Status: RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, , Italy

Site Status: NOT_YET_RECRUITING

Fondazione IRCCS Policlinico San Matteo, Pavia

Pavia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Riccardo Caccialanza

Role: CONTACT

r.caccialanza@smatteo.pv.it

+39 0382501615

Cristina Bosetti

Role: CONTACT

cristina.bosetti@marionegri.it

Facility Contacts

Antonella Daniele

Role: primary

Giovanni de Pergola

Role: primary

Rosalisa Cici

Role: backup

Alessandra Longhi

Role: primary

Toni Ibrahim

Role: backup

Patrizia Serra

Role: primary

Samir Guseppe Sukkar

Role: primary

Roberto Mele

Role: primary

Renato Cannizzaro

Role: primary

Maria Teresa Nardi

Role: primary

Marco Tonello

Role: backup

Debora Pezzuolo

Role: primary

Cristina Fortes

Role: primary

Lupe Sanchez Mete

Role: primary

Carmelo Pozzo

Role: primary

Maria Cristina Mele

Role: backup

Filippo Montemurro

Role: primary

Valentina Casalone

Role: backup

Stefania Gori

Role: primary

Vincenzo Quagliariello

Role: primary

Riccardo Caccialanza

Role: primary

Paolo Pedrazzoli

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 28710645 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32110247 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32384639 (View on PubMed)

Other Identifiers

IRMO

Identifier Type: -

Identifier Source: org_study_id