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Recruiting NCT07412379

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

Observational Cancer Abdomen Elderly (People Aged 65 or More) Quality of Life Sarcopenia in Elderly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cancer Abdomen, Elderly (People Aged 65 or More), Quality of Life, Sarcopenia in Elderly. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Colombia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Predictive factors associated with functional and quality of life decline at 12 months [Time frame: 12 months]
  • Predictive factors associated with oncological outcomes [Time frame: 5 years]
Secondary outcome measures (8)
  • Population characterization [Time frame: 5 years]
  • Surgical and functional outcomes [Time frame: 1 year]
  • Oncological outcomes [Time frame: 5 years]
  • Comparison [Time frame: 1 year]
  • Qualitative evaluation [Time frame: 1 year]
  • Oncological evaluation [Time frame: 5 years]
  • Subgroup analysis [Time frame: 1 year]
  • Internal validation [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Colombia · 1 center
  • Hospital Universitario Mayor-Méderi — Bogotá

Identifiers

NCT: NCT07412379 · A-035-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗