CancerIRMONCT06337019
The Italian Registry of Malnutrition in Oncology
An observational study of Cancer and Cancer Metastatic, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 16 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer Metastatic
- What is being tested?
- Cohort observational
- How many people
- 1,500 participants
- Where
- 16 sitesItaly
- Study dates
- 25 Oct 2022to Oct 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Impossibility to undertake the expected measurements;
- Impossibility to guarantee the attendance of the follow-up visits.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cristina Bosetti contact
16 sites in 1 country
Italy16 sites, 16 recruiting
- Recruiting
Centro di Riferimento Oncologico
Aviano, PN
Renato Cannizzaro
- Not yet recruiting
IRCCS Istituto Tumori Giovanni Paolo II,
Bari, BA
Antonella Daniele
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, BO
Alessandra Longhi
Toni Ibrahim
- Recruiting
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, TO
Filippo Montemurro
Valentina Casalone
- Recruiting
IRCCS Saverio De Bellis
Castellana Grotte, BA
Giovanni de Pergola
Rosalisa Cici
- Not yet recruiting
IRCCS Ospedale Policlinico San Martino
Genova, GE
Samir Guseppe Sukkar
- Recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS
Meldola, FC
Patrizia Serra
- Recruiting
IRCCS Ospedale San Raffaele, Milano
Milan, MI
Roberto Mele
- Not yet recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples
Vincenzo Quagliariello
- Recruiting
IRCCS Sacro Cuore Don Calabria
Negrar, VR
Stefania Gori
- Recruiting
IOV Istituto Oncologico Veneto
Padova, PV
Maria Teresa Nardi
Marco Tonello
- Recruiting
Fondazione IRCCS Policlinico San Matteo, Pavia
Pavia
Riccardo Caccialanza
Paolo Pedrazzoli
- Recruiting
AUSL IRCCS Reggio-Emilia
Reggio Emilia, RE
Debora Pezzuolo
- Recruiting
IDI IRCCS - Istituto Dermopatico dell'Immacolata
Roma, RM
Cristina Fortes
- Recruiting
Istituto Nazionale Tumori Regina Elena
Roma, RM
Lupe Sanchez Mete
- Recruiting
Policlinico Universitario Agostino Gemelli
Roma, RM
Carmelo Pozzo
Maria Cristina Mele
About this study
Official 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)
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.
Read the 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
- Being tested
- Cohort observational
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort observationalOther
Cohort observational
| Study group | Role | What they receive |
|---|---|---|
| Cohort observational | Overall study cohort Receives: Other: Cohort observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Percentage of patients who are alive.
Measured: 1 year
Secondary outcomes (2)
Progression-free survival
Percentage of patients who are free from tumor progression.
Measured: 1 year and 2 years
Treatment toxicity
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start25 Oct 2022
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337019
- Sponsor's protocol ID
- IRMO
- Acronym
- IRMO
- Status last verified
- Apr 2024
- First submitted
- 21 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 28710645Caccialanza 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.
PubMed 32110247Pedrazzoli 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.
PubMed 32384639
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06337019
- Acronym / sponsor ID
- IRMO / IRMO
- Conditions
- Cancer, Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort observational | – | Other: Cohort observationalOverall study cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Impossibility to undertake the expected measurements;
- Impossibility to guarantee the attendance of the follow-up visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort observationalCohort observational | Other | Cohort observational |
Primary outcome
Overall survival
Time frame: 1 year
Percentage of patients who are alive.
2 secondary outcomes
Progression-free survival
Time frame: 1 year and 2 years
Treatment toxicity
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 28710645Caccialanza 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.
- Background: PubMed 32110247Caccialanza 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.
- Background: PubMed 32384639Pedrazzoli 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Bosetti contact
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cancer Metastatic, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 16 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riccardo Caccialanza (+39 0382501615, r.caccialanza@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06337019, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.