Body Composition and Psychosocial Factors in ICI-Treated Cancer Patients
Evaluation of Body Composition, Psychosocial Factors, and Drug-Related Problems in Relation to Clinical Progression in Cancer Patients Receiving Immune Checkpoint Inhibitors
1 other identifier
observational
200
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2025
CompletedFirst Posted
Study publicly available on registry
August 19, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedAugust 24, 2025
August 1, 2025
Same day
August 6, 2025
August 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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
Throughout 6 months of follow-up.
Drug Related Problems
Throughout 6 months of follow-up.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Did not provide written informed consent
- Patients deemed unsuitable by the physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University Faculty of Pharmacy, Department of Clinical Pharmacy
Ankara, Altındağ, 06100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD candidate
Study Record Dates
First Submitted
August 6, 2025
First Posted
August 19, 2025
Study Start
September 1, 2025
Primary Completion
September 1, 2025
Study Completion
January 1, 2026
Last Updated
August 24, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share