Registry to monitor malnutrition in cancer patients

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)

This study is trying to see how tracking nutrition in newly diagnosed or treated cancer patients can help improve their health and quality of life.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia (Academic / other)
• Locations: 16 sites (Bari, BA and 15 other locations)
• Trial ID: NCT06337019 on ClinicalTrials.gov

What this trial studies

The Italian Registry of Malnutrition in Oncology (IRMO) aims to create a digital register for newly diagnosed or treated cancer patients to monitor their nutritional status and identify malnutrition early. This multicentric longitudinal observational study will collect real-world clinical data on malnutrition in oncology across Italy, focusing on its implications for overall survival and quality of life. By establishing a prospective cohort, the study seeks to improve nutritional care practices and management for cancer patients undergoing active treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a new diagnosis of specific cancers who are eligible for active treatment.

Not a fit: Patients who are unable to undertake the expected measurements or guarantee attendance at follow-up visits may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved nutritional support and management for cancer patients, potentially enhancing their survival and quality of life.

How similar studies have performed: While this approach is focused on collecting real-world data, similar studies have shown that improved nutritional management can positively impact cancer patient outcomes.

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.

Where this trial is running

Bari, BA and 15 other locations

• IRCCS Istituto Tumori Giovanni Paolo II, — Bari, Ba, Italy (Not_yet_recruiting)
• IRCCS Saverio De Bellis — Castellana Grotte, Ba, Italy (Recruiting)
• Istituto Ortopedico Rizzoli — Bologna, Bo, Italy (Recruiting)
• Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS — Meldola, Fc, Italy (Recruiting)
• IRCCS Ospedale Policlinico San Martino — Genova, Ge, Italy (Not_yet_recruiting)
• IRCCS Ospedale San Raffaele, Milano — Milan, Mi, Italy (Recruiting)
• Centro di Riferimento Oncologico — Aviano, Pn, Italy (Recruiting)
• IOV Istituto Oncologico Veneto — Padova, Pv, Italy (Recruiting)
• AUSL IRCCS Reggio-Emilia — Reggio Emilia, Re, Italy (Recruiting)
• IDI IRCCS - Istituto Dermopatico dell'Immacolata — Roma, Rm, Italy (Recruiting)
• Istituto Nazionale Tumori Regina Elena — Roma, Rm, Italy (Recruiting)
• Policlinico Universitario Agostino Gemelli — Roma, Rm, Italy (Recruiting)
• Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS — Candiolo, To, Italy (Recruiting)
• IRCCS Sacro Cuore Don Calabria — Negrar, Vr, Italy (Recruiting)
• Istituto Nazionale Tumori IRCCS Fondazione G. Pascale — Naples, Italy (Not_yet_recruiting)
• Fondazione IRCCS Policlinico San Matteo, Pavia — Pavia, Italy (Recruiting)

Study contacts

• Study coordinator: Riccardo Caccialanza

Conditions Cancer; Cancer Metastatic