Predictive Factors for Functional and Quality of Life Decline in Patients >65 Years With a Gastrointestinal Tract Cancer Diagnosis Taken to Curative Resectable Surgery

Predictive Factors Associated With Functional Decline and Quality of Life Decline at 12 Months Follow-up and 5 Year Oncological Follow-up in Patients >65 Yares With a Gastrointestinal Tract Cancer Diagnosis Taken to Resectable Surgery With a Curative Intent in Hospital Universitario Mayor-Méderi, Bogotá, Colombia

Introduction: Human life expectancy has increased significantly, leading to a transformation in the global demographic structure. Cancer is considerably more common among older adults compared to younger populations, as age is one of the main risk factors for its development. In fact, most solid tumors are considered age-related diseases. For this reason, the incidence of cancer among older individuals is expected to continue rising. Oncological care for this population group is particularly complex and represents a significant challenge, as comorbidities and the social aspects of aging create clinical scenarios that differ greatly from those seen in younger patients.

Objective: To identify the predictive factors of functional decline and quality of life at 12 months of follow-up, as well as oncological outcomes at 5 years of follow-up, in patients aged 65 years and older with gastrointestinal cancer who undergo curative-intent resective surgery at Hospital Universitario Mayor - Méderi, Bogotá, Colombia.

Methodology: Longitudinal and analytical observational study of prospective prognostic cohort type.

Expected Results: Predictive model of functional decline and quality of life, as well as oncological outcomes, in patients with gastrointestinal cancer undergoing curative-intent surgical procedures.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Cancer Abdomen; Elderly (People Aged 65 or More); Sarcopenia in Elderly; Functional Autonomy Level

• Study Type: Observational
• Enrollment (Estimated): 327

Contacts and Locations

• Study Contact: Name: Camilo Ramírez-Giraldo, Surgeon; Phone Number: 3206770474; Email: ramirezgiraldocamilo@gmail.com

Study Locations

• Colombia
  • Bogotá, Colombia
    • Recruiting
    • Hospital Universitario Mayor-Méderi
    • Contact: Camilo Ramírez-Giraldo, Surgeon; Phone Number: 3206770474; Email: ramirezgiraldocamilo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent in the Hospital Universitario Mayor - Méderi, Bogotá, Colombia.

Description

Inclusion Criteria:

• Gastrointestinal cancer tract diagnosis (oesophagus, stomach, duodenum, pancreas, liver, biliary tract, small bowel, appendix, colon and rectum)
• Have resectable disease by surgery
• Taken to surgery by curative intent
• Willingness to participate and enrollment by informed consent
• Attended in the Mederi Hospital Networn

Exclusion Criteria:

• Mortality
• Loss to follow-up
• Not taken to surgery
• Emergency surgery
• Taken to surgery as an oncological relapse or due to complications previous to an index procedure
• Endoscopical treatment
• Second primary tumor without a minimum 5 year disease free period from the primary one
• Basal functionality 0/6 by Katz score.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients aged over 65 years with a gastrointestinal tract cancer diagnosis; Patients aged over 65 years with a gastrointestinal tract cancer diagnosis that are taken to surgery with a curative intent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive factors associated with functional and quality of life decline at 12 months	Factors associated with functional and quality of life decline at 12 months follow-up	12 months
Predictive factors associated with oncological outcomes	Predictive factors associated with oncological outcomes	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Population characterization	To describe demographical, clinical, paraclinical, presurgical functional and of quality of life, and surgical outcomes in patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent	5 years
Surgical and functional outcomes	To describe postoperative surgical (mortality and complicactions) and functional and of quality of life outcomes at 1, 6, and 12 months followup in patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent	1 year
Oncological outcomes	To describe oncological outcomes (overall survival, disease-free period, disease-specific survival) in patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent at 1, 3 and 5 years follow-up	5 years
Comparison	To compare demographical, clinical, surgical, functional and of quality of life, and surgical outcomes in patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent that had functional and quality of life decline versus those that did not at 1, 6 and 12 months follow-up	1 year
Qualitative evaluation	To evaluate predictive demographical, clinical, paraclinical factorsfor functional and of quality of life, and surgical for in patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent at 1, 6 and 12 months follow-up	1 year
Oncological evaluation	To evaluate predictive demographical, clinical, paraclinical, presurgical, functional and of quality of life, and surgical factors for overall survival, disease-free period and disease-free survival in patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent at 1, 3 and 5 years follow-up	5 years
Subgroup analysis	To explore functional and quality of life decline at 1, 6 and 12 months follow-up by subgroups according to decade groups.	1 year
Internal validation	To perform an internal validation of a predictive model for functional and quality of life decline at 12 months follow-up in patients ≥65 years of age with a gastrointestinal tract cancer diagnosis taken to surgery with a curative intent	1 year

Collaborators and Investigators

• Sponsor: Hospital Universitario Mayor Méderi

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): December 15, 2029

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: A-035-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No