NCT05795374

Brief Summary

Several patients that suffer from gastrointestinal (GI) cancer are characterized by malnutrition and impairment of their functional status. The aim of the present study is to evaluate the nutritional condition of patients undergoing surgery due to GI cancer and compare it with their functional status. All consecutive patients with esophageal, gastric, colorectal, hepatocellular, pancreatic and biliary cancer, that underwent a surgical operation will be included. Demographic characteristics, nutritional assessment and anthropometric measurements of the patients will be recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 5, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

1.8 years

First QC Date

March 5, 2023

Last Update Submit

December 27, 2023

Conditions

Gastrointestinal Cancer

Keywords

nutritional statusfunctional statusgastrointestinal cancer

Outcome Measures

Primary Outcomes (1)

  • Postoperative morbidity.

    Complications after surgery.

    30 days

Secondary Outcomes (3)

  • Mortality.

    30 days

  • Disease stage

    1 month

  • Recurrence

    1 year

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with esophageal, gastric, colorectal, hepatocellular, pancreatic and biliary cancer, that underwent a surgical operation.

You may qualify if:

  • Patients undergoing a surgical operation due to esophageal, gastric, colorectal, hepatocellular, pancreatic and biliary cancer.

You may not qualify if:

  • Under 18 years old or above 99 years old.
  • Surgery due to benign conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hippocration General Hospital

Athens, 11527, Greece

Location

Related Publications (5)

  • Pathirana AK, Lokunarangoda N, Ranathunga I, Santharaj WS, Ekanayake R, Jayawardena R. Prevalence of hospital malnutrition among cardiac patients: results from six nutrition screening tools. Springerplus. 2014 Aug 7;3:412. doi: 10.1186/2193-1801-3-412. eCollection 2014.

    PMID: 25143874BACKGROUND

  • Pirlich M, Schutz T, Norman K, Gastell S, Lubke HJ, Bischoff SC, Bolder U, Frieling T, Guldenzoph H, Hahn K, Jauch KW, Schindler K, Stein J, Volkert D, Weimann A, Werner H, Wolf C, Zurcher G, Bauer P, Lochs H. The German hospital malnutrition study. Clin Nutr. 2006 Aug;25(4):563-72. doi: 10.1016/j.clnu.2006.03.005. Epub 2006 May 15.

    PMID: 16698132BACKGROUND

  • Huhmann MB, Cunningham RS. Importance of nutritional screening in treatment of cancer-related weight loss. Lancet Oncol. 2005 May;6(5):334-43. doi: 10.1016/S1470-2045(05)70170-4.

    PMID: 15863382BACKGROUND

  • Gomes de Lima KV, Maio R. Nutritional status, systemic inflammation and prognosis of patients with gastrointestinal cancer. Nutr Hosp. 2012 May-Jun;27(3):707-14. doi: 10.3305/nh/2012.27.3.5567.

    PMID: 23114934BACKGROUND

  • Leandro-Merhi VA, de Aquino JL. Determinants of malnutrition and post-operative complications in hospitalized surgical patients. J Health Popul Nutr. 2014 Sep;32(3):400-10.

    PMID: 25395903BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and adipose tissue.

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Konstantinos G Toutouzas, MD PhD

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

March 5, 2023

First Posted

April 3, 2023

Study Start

March 1, 2022

Primary Completion

December 20, 2023

Study Completion

December 20, 2023

Last Updated

December 28, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)