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NCT Number: 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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Mayor-Méderi

Bogotá, Colombia

Location status: Recruiting

Location contact

Camilo Ramírez-Giraldo, Surgeon

CONTACT

[email protected]

3206770474

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Predictive factors associated with functional and quality of life decline at 12 months

    Time frame: 12 months

    Factors associated with functional and quality of life decline at 12 months follow-up

  2. Predictive factors associated with oncological outcomes

    Time frame: 5 years

    Predictive factors associated with oncological outcomes

Secondary outcomes

  1. Population characterization

    Time frame: 5 years

    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

  2. Surgical and functional outcomes

    Time frame: 1 year

    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

  3. Oncological outcomes

    Time frame: 5 years

    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

  4. Comparison

    Time frame: 1 year

    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

  5. Qualitative evaluation

    Time frame: 1 year

    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

  6. Oncological evaluation

    Time frame: 5 years

    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

  7. Subgroup analysis

    Time frame: 1 year

    To explore functional and quality of life decline at 1, 6 and 12 months follow-up by subgroups according to decade groups.

  8. Internal validation

    Time frame: 1 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Camilo Ramírez-Giraldo, Surgeon

CONTACT

[email protected]

3206770474

Sponsors and collaborators

Lead sponsor

Hospital Universitario Mayor Méderi

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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