NCT06869707

Brief 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. The aim of the study is to improve clinical practice by using and testing the digital platform NUTRACARE in 5 different Centers.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

14 days

First QC Date

March 6, 2025

Last Update Submit

March 6, 2025

Conditions

Gastrointestinal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Nutritional intervention

    Number and type of nutritional interventions required

    15 days

Secondary Outcomes (1)

  • Complications

    up tp 30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with gastrointestinal neoplasms

You may qualify if:

  • \<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

You may not qualify if:

  • \>18 years
  • Pregnancy
  • Emergency
  • ECOG ≥ 3
  • Peritoneal involvement
  • Inability to provide informed consent
  • Informed consent refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Roma, Italy

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Domenico D'Ugo

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 11, 2025

Study Start

July 3, 2023

Primary Completion

July 17, 2023

Study Completion

July 1, 2025

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations

IT(1)