Cancer AbdomenNCT07412379
Functional Decline and Quality of Life After Gastrointestinal Cancer Surgery in Older Adults
An observational study of Cancer Abdomen and Elderly (People Aged 65 or More), run by Hospital Universitario Mayor Méderi at 1 site in Colombia.
Trial summary
This prospective cohort study will evaluate functional decline, health-related quality of life, and long-term oncological outcomes in adults aged 65 years and older undergoing curative-intent resective surgery for gastrointestinal cancer at Hospital Universitario Mayor-Méderi in Bogotá, Colombia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer Abdomen, Elderly (People Aged 65 or More), Quality of Life
- How many people
- 590 participants
- Where
- 1 siteColombia
- Study dates
- 28 Feb 2026to 15 Dec 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Hospital Universitario Mayor-Méderi
Bogotá
Camilo Ramírez-Giraldo, Surgeon, 3206770474, ramirezgiraldocamilo@gmail.com
About this study
Official title: Prognostic Factors for Functional Decline and Quality-of-life Deterioration After Curative-intent Gastrointestinal Cancer Surgery in Older Adults: Protocol for a Prospective Cohort Study at a University Hospital
This prospective cohort study will evaluate functional decline, health-related quality of life, and long-term oncological outcomes in adults aged 65 years and older undergoing curative-intent resective surgery for gastrointestinal cancer at Hospital Universitario Mayor-Méderi in Bogotá, Colombia.
The primary objectives are to identify prognostic factors associated with functional decline and clinically meaningful deterioration in health-related quality of life at 12 months after surgery. Functional decline will be assessed using the Katz Index of Independence in Activities of Daily Living, and quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Long-term oncological outcomes will include overall survival, time to recurrence, and disease-free survival, with estimates reported at 1, 3, and 5 years after surgery.
Participants will undergo standardized preoperative assessment of demographic, oncological, functional, frailty, nutritional, cognitive, psychological, and sarcopenia-related factors. Multivariable prognostic models will be developed to evaluate their association with the primary outcomes.
Read the detailed description
This is a prospective longitudinal prognostic cohort study conducted at Hospital Universitario Mayor-Méderi in Bogotá, Colombia. The study aims to identify prognostic factors associated with functional decline and clinically meaningful deterioration in health-related quality of life after curative-intent resective surgery for gastrointestinal cancer in adults aged 65 years and older. The target recruitment sample is 590 participants. The development, internal validation, and reporting of the prognostic models will be guided by the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis + Artificial Intelligence (TRIPOD+AI) statement.
The study includes two follow-up phases. During the first 12 months after surgery, functional status and health-related quality of life will be assessed at baseline and at 1, 6, and 12 months. Functional status will be measured using the Katz Index of Independence in Activities of Daily Living, which ranges from 0 to 6, with higher scores indicating greater independence. Functional decline will be defined as a decrease of at least 1 point from the preoperative baseline Katz score at 12 months. Health-related quality of life will be assessed using the Spanish-language version 3.0 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The primary quality-of-life outcome will be deterioration in the Global Health Status/Quality of Life scale, with a decrease of at least 10 points from baseline considered clinically meaningful.
Preoperative candidate predictors will include age, tumour stage, baseline functional status, frailty assessed using the FRAIL Scale, nutritional status assessed using the Mini Nutritional Assessment-Short Form, depressive symptoms assessed using the Geriatric Depression Scale-15, cognitive status assessed using the Mini-Mental State Examination, and probable sarcopenia assessed using SARC-F and handgrip strength. Multivariable logistic regression models will be developed for the two primary 12-month outcomes, and internal validation will be performed using bootstrap resampling.
During long-term follow-up, oncological outcomes will include overall survival, time to recurrence, and disease-free survival. Overall survival will be defined as the time from surgery to death from any cause. Time to recurrence will be defined as the time from surgery to the first documented recurrence of the index gastrointestinal malignancy, with death without prior recurrence treated as a competing event. Disease-free survival will be defined as the time from surgery to the first documented recurrence or death from any cause, whichever occurs first. These outcomes will be evaluated throughout follow-up, with estimates reported at 1, 3, and 5 years after surgery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Functional decline based on the Katz Index of Independence in Activities of Daily Living
Functional decline will be defined as a decrease of at least 1 point from the preoperative baseline score on the Katz Index of Independence in Activities of Daily Living at 12 months after surgery. The Katz Index ranges from 0 to 6, with higher scores indicating greater independence in basic activities of daily living.
Measured: From preoperative baseline to 12 months after surgery
Clinically meaningful deterioration in global health status/quality of life assessed with the EORTC QLQ-C30
Clinically meaningful deterioration in health-related quality of life will be defined as a decrease of at least 10 points from the preoperative baseline score on the Global Health Status/Quality of Life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, version 3.0, at 12 months after surgery. This scale ranges from 0 to 100, with higher scores indicating better global health status and quality of life.
Measured: From preoperative baseline to 12 months after surgery
Secondary outcomes (3)
Overall survival
Overall survival will be defined as the time from surgery to death from any cause. Participants who are alive at the end of follow-up will be censored at the date of their last known follow-up. Survival estimates will be reported at 1, 3, and 5 years after surgery.
Measured: From surgery through 5 years of follow-up
Time to recurrence
Time to recurrence will be defined as the time from surgery to the first documented recurrence of the index gastrointestinal malignancy. Death without prior documented recurrence will be considered a competing event. Estimates will be reported at 1, 3, and 5 years after surgery.
Measured: From surgery through 5 years of follow-up
Disease-free survival
Disease-free survival will be defined as the time from surgery to the first documented recurrence of the index gastrointestinal malignancy or death from any cause, whichever occurs first. Disease-free survival estimates will be reported at 1, 3, and 5 years after surgery.
Measured: From surgery through 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start28 Feb 2026
- Primary completion1 Mar 2029 (estimated)
- Study completion15 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 590 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Mayor Méderi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilo Ramirez Giraldo, Hospital Universitario Mayor Méderi
- Investigators
- Jose Daza, MD, Msc, Study chair, Mederi Hospital Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412379
- Sponsor's protocol ID
- A-035-2025
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the reported study results may be made available to qualified researchers upon reasonable request after publication, subject to institutional and ethical requirements and any applicable data-sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors for Functional Decline and Quality-of-life Deterioration After Curative-intent Gastrointestinal Cancer Surgery in Older Adults: Protocol for a Prospective Cohort Study at a University Hospital
- ClinicalTrials.gov ID
- NCT07412379
- Acronym / sponsor ID
- A-035-2025
- Conditions
- Cancer Abdomen, Elderly (People Aged 65 or More), Quality of Life, Sarcopenia in Elderly, Functional Autonomy Level
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Hospital Universitario Mayor MéderiUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 15 Dec 2033 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective cohort study will evaluate functional decline, health-related quality of life, and long-term oncological outcomes in adults aged 65 years and older undergoing curative-intent resective surgery for gastrointestinal cancer at Hospital Universitario Mayor-Méderi in Bogotá, Colombia.
The primary objectives are to identify prognostic factors associated with functional decline and clinically meaningful deterioration in health-related quality of life at 12 months after surgery. Functional decline will be assessed using the Katz Index of Independence in Activities of Daily Living, and quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Long-term oncological outcomes will include overall survival, time to recurrence, and disease-free survival, with estimates reported at 1, 3, and 5 years after surgery.
Participants will undergo standardized preoperative assessment of demographic, oncological, functional, frailty, nutritional, cognitive, psychological, and sarcopenia-related factors. Multivariable prognostic models will be developed to evaluate their association with the primary outcomes.
Detailed description
This is a prospective longitudinal prognostic cohort study conducted at Hospital Universitario Mayor-Méderi in Bogotá, Colombia. The study aims to identify prognostic factors associated with functional decline and clinically meaningful deterioration in health-related quality of life after curative-intent resective surgery for gastrointestinal cancer in adults aged 65 years and older. The target recruitment sample is 590 participants. The development, internal validation, and reporting of the prognostic models will be guided by the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis + Artificial Intelligence (TRIPOD+AI) statement.
The study includes two follow-up phases. During the first 12 months after surgery, functional status and health-related quality of life will be assessed at baseline and at 1, 6, and 12 months. Functional status will be measured using the Katz Index of Independence in Activities of Daily Living, which ranges from 0 to 6, with higher scores indicating greater independence. Functional decline will be defined as a decrease of at least 1 point from the preoperative baseline Katz score at 12 months. Health-related quality of life will be assessed using the Spanish-language version 3.0 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The primary quality-of-life outcome will be deterioration in the Global Health Status/Quality of Life scale, with a decrease of at least 10 points from baseline considered clinically meaningful.
Preoperative candidate predictors will include age, tumour stage, baseline functional status, frailty assessed using the FRAIL Scale, nutritional status assessed using the Mini Nutritional Assessment-Short Form, depressive symptoms assessed using the Geriatric Depression Scale-15, cognitive status assessed using the Mini-Mental State Examination, and probable sarcopenia assessed using SARC-F and handgrip strength. Multivariable logistic regression models will be developed for the two primary 12-month outcomes, and internal validation will be performed using bootstrap resampling.
During long-term follow-up, oncological outcomes will include overall survival, time to recurrence, and disease-free survival. Overall survival will be defined as the time from surgery to death from any cause. Time to recurrence will be defined as the time from surgery to the first documented recurrence of the index gastrointestinal malignancy, with death without prior recurrence treated as a competing event. Disease-free survival will be defined as the time from surgery to the first documented recurrence or death from any cause, whichever occurs first. These outcomes will be evaluated throughout follow-up, with estimates reported at 1, 3, and 5 years after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional decline based on the Katz Index of Independence in Activities of Daily Living
Time frame: From preoperative baseline to 12 months after surgery
Functional decline will be defined as a decrease of at least 1 point from the preoperative baseline score on the Katz Index of Independence in Activities of Daily Living at 12 months after surgery. The Katz Index ranges from 0 to 6, with higher scores indicating greater independence in basic activities of daily living.
Clinically meaningful deterioration in global health status/quality of life assessed with the EORTC QLQ-C30
Time frame: From preoperative baseline to 12 months after surgery
Clinically meaningful deterioration in health-related quality of life will be defined as a decrease of at least 10 points from the preoperative baseline score on the Global Health Status/Quality of Life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, version 3.0, at 12 months after surgery. This scale ranges from 0 to 100, with higher scores indicating better global health status and quality of life.
3 secondary outcomes
Overall survival
Time frame: From surgery through 5 years of follow-up
Time to recurrence
Time frame: From surgery through 5 years of follow-up
Disease-free survival
Time frame: From surgery through 5 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the reported study results may be made available to qualified researchers upon reasonable request after publication, subject to institutional and ethical requirements and any applicable data-sharing agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose Daza, MD, Msc study chair
Mederi Hospital Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Abdomen and Elderly (People Aged 65 or More), run by Hospital Universitario Mayor Méderi at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camilo Ramírez-Giraldo, Surgeon (3206770474, ramirezgiraldocamilo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional decline based on the Katz Index of Independence in Activities of Daily Living (time frame: From preoperative baseline to 12 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.