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NCT Number: NCT06337019

The Italian Registry of Malnutrition in Oncology

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Tumori Giovanni Paolo II,, Bari, BA, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cohort observational

Other

Cohort observational

Primary outcomes

  1. Overall survival

    Time frame: 1 year

    Percentage of patients who are alive.

Secondary outcomes

  1. Progression-free survival

    Time frame: 1 year and 2 years

    Percentage of patients who are free from tumor progression.

  2. Treatment toxicity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Bosetti

CONTACT

[email protected]

Riccardo Caccialanza

CONTACT

[email protected]

+39 0382501615

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Collaborators

  • Istituto Di Ricerche Farmacologiche Mario Negri

Registry information

Official study title

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)

Acronym: IRMO

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 29, 2024
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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