CancerNCT07130981
Body Composition and Psychosocial Factors in ICI-Treated Cancer Patients
An observational study of Cancer and Psychosocial Functioning, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Evaluation of the effects of body composition, psychosocial factors, and drug-related problems on clinical progression (such as toxicity, treatment response, and quality of life) in cancer patients treated with immune checkpoint inhibitors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Psychosocial Functioning, Treatment Side Effects
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Jan 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients initiating immune checkpoint inhibitor therapy (ipilimumab, nivolumab, pembrolizumab, atezolizumab, or avelumab) at the Medical Oncology Outpatient Clinic.
Who may be able to join
- Aged 18 years or older
- Having undergone a CT scan (at the L3 level) prior to treatment
- No severe mental disorder and able to communicate effectively
- Provided written informed consent
Who cannot join
- Did not provide written informed consent
- Patients deemed unsuitable by the physician
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University Faculty of Pharmacy, Department of Clinical Pharmacy
Ankara, Altındağ, 06100
Aygin Ekincioglu, Professor, (0 312) 305 20 43, aygin@hacettepe.edu.tr
About this study
Official title: Evaluation of Body Composition, Psychosocial Factors, and Drug-Related Problems in Relation to Clinical Progression in Cancer Patients Receiving Immune Checkpoint Inhibitors
Evaluation of the effects of body composition, psychosocial factors, and drug-related problems on clinical progression (such as toxicity, treatment response, and quality of life) in cancer patients treated with immune checkpoint inhibitors
- Conditions
- Cancer, Psychosocial Functioning, Treatment Side Effects, Cachexia
- Medical subject headings
- Neoplasms, Cachexia
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition evaluation
Body Composition Parameters Description: Muscle area, muscle index, muscle density, lean body mass, and combined indices derived from routine abdominal imaging at the L3 vertebral level.
Unit of measure: cm², cm²/m², Hounsfield units (HU), kilograms. Tool: Routine clinical imaging analysis.
Measured: Patient recruitment is planned to occur over a 6-month period. Each participant will be followed for a maximum duration of 6 months from the initiation of immunotherapy.
Secondary outcomes (2)
Cachexia and psychosocial factors evaluation
Cachexia Risk Scores Description: Composite scores reflecting cachexia status, based on multidimensional clinical and biochemical indicators.
Unit of measure: Scoring system Tool: Validated cachexia scoring system. Psychosocial Factor Scores Description: Scores representing levels of depression, anxiety, stress, and distress, assessed through validated self-report questionnaires.
Unit of measure: Questionnaire scores (scale ranges such as 0-21 or 0-10). Tool: Validated patient-reported outcome measures.
Measured: Throughout 6 months of follow-up.
Drug Related Problems
Drug-Related Problems (DRPs) Description: Number and type of drug-related problems identified during treatment follow-up.
Unit of measure: Count (number of problems per patient). Tool: Pharmaceutical Care Network Europe (PCNE) classification system. Immune-Related Adverse Events (irAEs) Description: Incidence and severity of immune-related adverse events occurring during immunotherapy.
Unit of measure: Percentage of patients; severity graded 1-5. Tool: Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Measured: Throughout 6 months 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 posted19 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İzgi Bayraktar, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130981
- Sponsor's protocol ID
- SBA 25/672
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Body Composition, Psychosocial Factors, and Drug-Related Problems in Relation to Clinical Progression in Cancer Patients Receiving Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT07130981
- Acronym / sponsor ID
- SBA 25/672
- Conditions
- Cancer, Psychosocial Functioning, Treatment Side Effects, Cachexia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 19 Aug 2025 (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.
Evaluation of the effects of body composition, psychosocial factors, and drug-related problems on clinical progression (such as toxicity, treatment response, and quality of life) in cancer patients treated with immune checkpoint inhibitors
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients initiating immune checkpoint inhibitor therapy (ipilimumab, nivolumab, pembrolizumab, atezolizumab, or avelumab) at the Medical Oncology Outpatient Clinic.
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Having undergone a CT scan (at the L3 level) prior to treatment
- No severe mental disorder and able to communicate effectively
- Provided written informed consent
Key exclusion criteria (2 listed)
- Did not provide written informed consent
- Patients deemed unsuitable by the physician
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
Body composition evaluation
Time frame: Patient recruitment is planned to occur over a 6-month period. Each participant will be followed for a maximum duration of 6 months from the initiation of immunotherapy.
Body Composition Parameters Description: Muscle area, muscle index, muscle density, lean body mass, and combined indices derived from routine abdominal imaging at the L3 vertebral level. Unit of measure: cm², cm²/m², Hounsfield units (HU), kilograms. Tool: Routine clinical imaging analysis.
2 secondary outcomes
Cachexia and psychosocial factors evaluation
Time frame: Throughout 6 months of follow-up.
Drug Related Problems
Time frame: Throughout 6 months 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 24 Aug 2025.
- Individual participant dataSharing planned: No
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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.
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 and Psychosocial Functioning, run by Hacettepe University at 1 site in Turkey (Türkiye).
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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. 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 Turkey (Türkiye). 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 İzgi BAYRAKTAR, PhD (c)- Lecturer (+905342996472, izgibayraktar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition evaluation (time frame: Patient recruitment is planned to occur over a 6-month period. Each participant will be followed for a maximum duration of 6 months from the initiation of immunotherapy.). 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 24 Aug 2025.