SarcopeniaNCT07761481
CT-Determined Sarcopenia and Mortality in Critically Ill Cancer Patients
An observational study of Sarcopenia and Cancer, run by Hospital H+ Queretaro at 1 site in Mexico.
Trial summary
The goal of this observational study is to evaluate the association between computed tomography-determined sarcopenia and muscle quality impairment with 28-day mortality in adult patients (aged 18 and older) with solid or hematologic malignancies admitted to the Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Cancer, Critical Illness
- What is being tested?
- Computed Tomography Muscle Assessment (HUAC)
- How many people
- 23 participants
- Where
- 1 siteMexico
- Study dates
- 10 Jul 2026to 5 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill adult cancer patients (with solid or hematological malignancies) admitted to the Intensive Care Unit (ICU) at Hospital H+ Querétaro between January 2022 and December 2025 who underwent abdominal CT scans during routine clinical management
Who may be able to join
- Adult patients aged 18 years or older.
- Confirmed diagnosis of solid or hematological malignancy.
- Admitted to the Intensive Care Unit (ICU) between January 1, 2022, and December 31, 2025.
- Availability of an abdominal computed tomography (CT) scan performed during routine clinical care at the time of or prior to ICU admission.
Who cannot join
- Missing or incomplete clinical, laboratory, or outcome data in the electronic medical record.
- Non-evaluable abdominal CT scans due to motion artifacts, metal artifacts, or lack of cross-sectional visibility of the bilateral psoas muscles.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital H+ Querétaro, Santiago de Querétaro, Querétaro
Querétaro City, Querétaro, 76030
About this study
Official title: Association Between Computed Tomography-Determined Sarcopenia and 28-Day Mortality in Critically Ill Cancer Patients: An Analytical Observational Study
The goal of this observational study is to evaluate the association between computed tomography-determined sarcopenia and muscle quality impairment with 28-day mortality in adult patients (aged 18 and older) with solid or hematologic malignancies admitted to the Intensive Care Unit (ICU).
The main question it aims to answer is: Is lower psoas muscle quality, calculated using the Hounsfield Unit Average Calculation (HUAC), associated with increased 28-day mortality in critically ill cancer patients? Researchers will compare patients who survived at 28 days with those who died to evaluate whether tomographic muscle measurements (HUAC and total psoas area) and clinical nutritional scores (mNUTRIC) differ between groups and predict mortality.
Read more
Participants' records will be evaluated through:
- A retrospective review of electronic medical records to collect demographic, clinical, oncologic, laboratory, and disease severity scores (APACHE II, SOFA, mNUTRIC).
- Quantitative tomographic assessment of the right and left psoas muscle area and radiation attenuation density (in Hounsfield Units) using existing computed tomography (CT) scans performed during routine clinical care.
- Follow-up of 28-day vital status (alive or deceased) after ICU admission.
- Conditions
- Sarcopenia, Cancer, Critical Illness, Malnutrition
- Being tested
- Computed Tomography Muscle Assessment (HUAC)
- Keywords
- Sarcopenia, Critically ill cancer patient, Computed tomography, Mortality
- Medical subject headings
- Sarcopenia, Neoplasms, Critical Illness, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography Muscle Assessment (HUAC)Other
Quantitative measurement of cross-sectional area and radiological density (Hounsfield Units) of the bilateral psoas muscles on abdominal CT scans obtained during routine care to calculate the Hounsfield Unit Average Calculation (HUAC).
| Study group | Role | What they receive |
|---|---|---|
| Survivors | Critically ill cancer patients admitted to the ICU who survived at 28 days post-admission. Receives: Other: Computed Tomography Muscle Assessment (HUAC) | |
| Non survivors | Critically ill cancer patients admitted to the ICU who died within 28 days post-admission Receives: Other: Computed Tomography Muscle Assessment (HUAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-Day All-Cause Mortality
Vital status (alive or deceased) of critically ill cancer patients evaluated at 28 days following their admission to the Intensive Care Unit (ICU). The association with muscle quality metrics, specifically the Hounsfield Unit Average Calculation (HUAC) of the psoas muscles obtained via computed tomography (CT) scan, will be assessed.
Measured: At 28 days post-ICU admission
Secondary outcomes (4)
Nutritional Risk Assessment via mNUTRIC Score
Evaluation of nutritional risk upon ICU admission using the modified Nutrition Risk in Critically Ill (mNUTRIC) score. The score ranges from 0 to 9 points, where 0 represents the lowest nutritional risk and 9 represents the highest nutritional risk (higher scores indicate a worse outcome/higher nutritional risk; a score > 5 indicates high nutritional risk).
Measured: Baseline (at ICU admission)
Total Psoas Muscle Cross-Sectional Area
Quantitative measurement of the total cross-sectional area of the right and left psoas muscles combined (mm^2 or cm^2) derived from abdominal computed tomography (CT) scans to assess muscle mass quantity.
Measured: Baseline (CT scans performed within routine care prior to or at ICU admission)
Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Assessment of clinical disease severity at ICU admission using the Acute Physiology and Chronic Health Evaluation II (APACHE II) score. The score ranges from 0 to 71 points, where 0 indicates no physiological impairment and 71 represents the most severe degree of illness (higher scores indicate greater disease severity and a higher risk of mortality).
Measured: At ICU admission (Baseline)
Sequential Organ Failure Assessment (SOFA) Score
Assessment of organ dysfunction at ICU admission using the Sequential Organ Failure Assessment (SOFA) score. The score ranges from 0 to 24 points, where 0 indicates normal organ function and 24 represents severe multi-organ failure (higher scores indicate greater organ dysfunction and worse prognosis).
Measured: Baseline (at ICU admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start10 Jul 2026
- Primary completion5 Aug 2026
- Study completion5 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital H+ Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761481
- Sponsor's protocol ID
- CEI2026-07/30/V1
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Computed Tomography-Determined Sarcopenia and 28-Day Mortality in Critically Ill Cancer Patients: An Analytical Observational Study
- ClinicalTrials.gov ID
- NCT07761481
- Acronym / sponsor ID
- CEI2026-07/30/V1
- Conditions
- Sarcopenia, Cancer, Critical Illness, Malnutrition
- Keywords
- Sarcopenia, Critically ill cancer patient, Computed tomography, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hospital H+ QueretaroUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 12 Aug 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.
The goal of this observational study is to evaluate the association between computed tomography-determined sarcopenia and muscle quality impairment with 28-day mortality in adult patients (aged 18 and older) with solid or hematologic malignancies admitted to the Intensive Care Unit (ICU).
The main question it aims to answer is: Is lower psoas muscle quality, calculated using the Hounsfield Unit Average Calculation (HUAC), associated with increased 28-day mortality in critically ill cancer patients? Researchers will compare patients who survived at 28 days with those who died to evaluate whether tomographic muscle measurements (HUAC and total psoas area) and clinical nutritional scores (mNUTRIC) differ between groups and predict mortality.
Participants' records will be evaluated through:
- A retrospective review of electronic medical records to collect demographic, clinical, oncologic, laboratory, and disease severity scores (APACHE II, SOFA, mNUTRIC).
- Quantitative tomographic assessment of the right and left psoas muscle area and radiation attenuation density (in Hounsfield Units) using existing computed tomography (CT) scans performed during routine clinical care.
- Follow-up of 28-day vital status (alive or deceased) after ICU admission.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Other: Computed Tomography Muscle Assessment (HUAC)Critically ill cancer patients admitted to the ICU who survived at 28 days post-admission. |
| Non survivors | – | Other: Computed Tomography Muscle Assessment (HUAC)Critically ill cancer patients admitted to the ICU who died within 28 days post-admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult cancer patients (with solid or hematological malignancies) admitted to the Intensive Care Unit (ICU) at Hospital H+ Querétaro between January 2022 and December 2025 who underwent abdominal CT scans during routine clinical management
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older.
- Confirmed diagnosis of solid or hematological malignancy.
- Admitted to the Intensive Care Unit (ICU) between January 1, 2022, and December 31, 2025.
- Availability of an abdominal computed tomography (CT) scan performed during routine clinical care at the time of or prior to ICU admission.
Key exclusion criteria (2 listed)
- Missing or incomplete clinical, laboratory, or outcome data in the electronic medical record.
- Non-evaluable abdominal CT scans due to motion artifacts, metal artifacts, or lack of cross-sectional visibility of the bilateral psoas muscles.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed Tomography Muscle Assessment (HUAC)Quantitative measurement of cross-sectional area and radiological density (Hounsfield Units) of the bilateral psoas muscles on abdominal CT scans obtained during routine care to calculate the Hounsfield Unit Average Calculation (HUAC). | Other | Non survivors, Survivors |
Primary outcome
28-Day All-Cause Mortality
Time frame: At 28 days post-ICU admission
Vital status (alive or deceased) of critically ill cancer patients evaluated at 28 days following their admission to the Intensive Care Unit (ICU). The association with muscle quality metrics, specifically the Hounsfield Unit Average Calculation (HUAC) of the psoas muscles obtained via computed tomography (CT) scan, will be assessed.
4 secondary outcomes
Nutritional Risk Assessment via mNUTRIC Score
Time frame: Baseline (at ICU admission)
Total Psoas Muscle Cross-Sectional Area
Time frame: Baseline (CT scans performed within routine care prior to or at ICU admission)
Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Time frame: At ICU admission (Baseline)
Sequential Organ Failure Assessment (SOFA) Score
Time frame: Baseline (at ICU admission)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Sarcopenia and Cancer, run by Hospital H+ Queretaro at 1 site in Mexico.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 12 Aug 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-Day All-Cause Mortality (time frame: At 28 days post-ICU admission). 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 12 Aug 2026.