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

NCT07412379 | Recruiting DMC

• 1 other identifier: A-035-2025
• Study Type: observational
• Target: 327
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Abdomen; Elderly (People Aged 65 or More); Quality of Life; Sarcopenia in Elderly; Functional Autonomy Level

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Population characterization

  5 years

• Surgical and functional outcomes

  1 year

• Oncological outcomes

  5 years

• Comparison

  1 year

• Qualitative evaluation

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Mayor Méderi: lead

Study Sites (1)

Hospital Universitario Mayor-Méderi

Bogotá, Colombia

RECRUITING

Central Study Contacts

Camilo Ramírez-Giraldo, Surgeon

CONTACT

3206770474; ramirezgiraldocamilo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): December 15, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CO (1)