Gastrointestinal NeoplasmsNUTRACARENCT06869707
Multidisciplinary Approach to Nutritional Support for Oncological Patients - NUTRACARE PROJECT
An observational study of Gastrointestinal Neoplasms, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Malnutrition correlated to increased perioperative morbidity occurs in patients with gastrointestinal malignancies. Adherence guidelines for nutritional assessment and support in oncological patients is unfortunately very low. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms
- How many people
- 85 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jul 2023to 1 Jul 2025
- 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: Patients with gastrointestinal neoplasms
Who may be able to join
- <18 years
- ECOG grade 0-2
- Patients undergoing elective surgery or first cycle of chemotherapy (neoadjuvant or adjuvant) for staged I-III colorectal, hepatobiliary-pancreatic and oesophago-gastric cancers
Who cannot join
- >18 years
- Pregnancy
- Emergency
- ECOG ≥ 3
- M+
- Peritoneal involvement
- Inability to provide informed consent
- Informed consent refusal
Trial locations and contacts
1 site in 1 country.
About this study
Malnutrition correlated to increased perioperative morbidity occurs in patients with gastrointestinal malignancies.
Adherence guidelines for nutritional assessment and support in oncological patients is unfortunately very low.
The aim of the study is to improve clinical practice by using and testing the digital platform NUTRACARE in 5 different Centers.
Read the detailed description
After being informed about the study, all the patients undergoing elective surgery or first cycle of neoadjuvant or adjuvant therapy giving written informed consent will be screened by the surgeon or the oncologist and the NRS-2002 (Nutrition Risk Screening) will be administered.
Patients who will be assessed at risk will be notified to the center nutritionist.
- Conditions
- Gastrointestinal Neoplasms
- Medical subject headings
- Gastrointestinal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional intervention
Number and type of nutritional interventions required
Measured: 15 days
Secondary outcomes (1)
Complications
Number and severity of surgical and oncological complications
Measured: up tp 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start3 Jul 2023
- Primary completion17 Jul 2023
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Domenico D'Ugo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869707
- Sponsor's protocol ID
- 4982
- Acronym
- NUTRACARE
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Approach to Nutritional Support for Oncological Patients - NUTRACARE PROJECT
- ClinicalTrials.gov ID
- NCT06869707
- Acronym / sponsor ID
- NUTRACARE / 4982
- Conditions
- Gastrointestinal Neoplasms
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 11 Mar 2025 (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.
Malnutrition correlated to increased perioperative morbidity occurs in patients with gastrointestinal malignancies.
Adherence guidelines for nutritional assessment and support in oncological patients is unfortunately very low.
The aim of the study is to improve clinical practice by using and testing the digital platform NUTRACARE in 5 different Centers.
Detailed description
After being informed about the study, all the patients undergoing elective surgery or first cycle of neoadjuvant or adjuvant therapy giving written informed consent will be screened by the surgeon or the oncologist and the NRS-2002 (Nutrition Risk Screening) will be administered.
Patients who will be assessed at risk will be notified to the center nutritionist.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gastrointestinal neoplasms
Key inclusion criteria (3 listed)
- <18 years
- ECOG grade 0-2
- Patients undergoing elective surgery or first cycle of chemotherapy (neoadjuvant or adjuvant) for staged I-III colorectal, hepatobiliary-pancreatic and oesophago-gastric cancers
Key exclusion criteria (8 listed)
- >18 years
- Pregnancy
- Emergency
- ECOG ≥ 3
- M+
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nutritional intervention
Time frame: 15 days
Number and type of nutritional interventions required
1 secondary outcome
Complications
Time frame: up tp 30 days
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 11 Mar 2025.
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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. This study is not recruiting at the moment.
Domenico D'Ugo principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Neoplasms, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional intervention (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2025.