The Italian Registry of Malnutrition in Oncology (IRMO)

April 2, 2024 updated by: Fondazione IRCCS Policlinico San Matteo di Pavia

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Napoli, Italy
        • Not yet recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
        • Contact:
          • Vincenzo Quagliariello
      • Pavia, Italy
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo, Pavia
        • Contact:
          • Riccardo Caccialanza
        • Contact:
          • Paolo Pedrazzoli
    • BA
      • Bari, BA, Italy
        • Not yet recruiting
        • IRCCS Istituto Tumori Giovanni Paolo II,
        • Contact:
          • Antonella Daniele
      • Castellana Grotte, BA, Italy
        • Recruiting
        • Irccs Saverio de Bellis
        • Contact:
          • Giovanni de Pergola
        • Contact:
          • Rosalisa Cici
    • BO
      • Bologna, BO, Italy
        • Recruiting
        • Istituto Ortopedico Rizzoli
        • Contact:
          • Alessandra Longhi
        • Contact:
          • Toni Ibrahim
    • FC
      • Meldola, FC, Italy
        • Recruiting
        • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS
        • Contact:
          • Patrizia Serra
    • GE
      • Genova, GE, Italy
        • Not yet recruiting
        • IRCCS Ospedale Policlinico San Martino
        • Contact:
          • Samir Guseppe Sukkar
    • MI
      • Milano, MI, Italy
        • Recruiting
        • IRCCS Ospedale San Raffaele, Milano
        • Contact:
          • Roberto Mele
    • PN
      • Aviano, PN, Italy
        • Recruiting
        • Centro Di Riferimento Oncologico
        • Contact:
          • Renato Cannizzaro
    • PV
      • Padova, PV, Italy
        • Recruiting
        • IOV Istituto Oncologico Veneto
        • Contact:
          • Maria Teresa Nardi
        • Contact:
          • Marco Tonello
    • RE
      • Reggio Emilia, RE, Italy
        • Recruiting
        • AUSL IRCCS Reggio-Emilia
        • Contact:
          • Debora Pezzuolo
    • RM
      • Roma, RM, Italy
        • Recruiting
        • IDI IRCCS - Istituto Dermopatico dell'Immacolata
        • Contact:
          • Cristina Fortes
      • Roma, RM, Italy
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena
        • Contact:
          • Lupe Sanchez Mete
      • Roma, RM, Italy
        • Recruiting
        • Policlinico Universitario Agostino Gemelli
        • Contact:
          • Carmelo Pozzo
        • Contact:
          • Maria Cristina Mele
    • TO
      • Candiolo, TO, Italy
        • Recruiting
        • Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
        • Contact:
          • Filippo Montemurro
        • Contact:
          • Valentina Casalone
    • VR
      • Negrar, VR, Italy
        • Recruiting
        • IRCCS Sacro Cuore Don Calabria
        • Contact:
          • Stefania Gori

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort observational
Overall study cohort
Other: Cohort observational
Cohort observational

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
Percentage of patients who are alive.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 1 year and 2 years
Percentage of patients who are free from tumor progression.
1 year and 2 years
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione IRCCS Policlinico San Matteo di Pavia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRMO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data derived from the study are property of the Promoter, who will commit to sharing them with the Investigators of each participating centres and to publish the results of the study in order to give full and timely information to the scientific community. The results of the research could be communicated to third parties and made public in conferences by the Investigators after accordance with the Study Responsible, in compliance with the Ministerial Decree of 2.05.2006.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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