Trial · NCT07886359
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Analysis of Serum Biomarkers (Serum CXCL9,CXCL11,CCL2,CCL5,IFN-γ,IL-10 concentration) | Before immunotherapy, week 12 and week 24 | Serum CXCL9,CXCL11,CCL2,CCL5,IFN-γ,IL-10 concentrations will be measured using ELISA. Results will be expressed in pg/mL. |
| Primary | Assesment of Absolute CD3+ , CD4+ , CD8+ , CD19+ T-lymphocyte counts, CD16/56+ Natural Killer cells | Before immunotherapy, week 12 and week 24 | Absolute CD3+ , CD4+ , CD8+ , CD19+ T-lymphocyte counts, CD16/56+ Natural Killer cells will be assessed by flow cytometry using the BD Multitest™ 6-Color TBNK reagent and BD FACSLyric™ flow cytometer. Absolute counts will be calculated using a dual-platform approach incorporating routine complete blood count data. Results will be expressed in cells/µL. |
| Primary | Analysis of Handgrip Strength | Before immunotherapy, week 12 and week 24 | Handgrip strength will be evaluated via hand dynamometer while one is upright seated in an armless chair, elbow flexed 90 degree and forearm positioned at midprone. Three repetitions will be collected, the mean of them will be recorded. Handgrip strength will be recorded as kilogram (kg). |
| Primary | Peripheral muscle strength | Before immunotherapy, week 12 and week 24 | Participants' peripheral muscle strength will be assessed using a digital hand dynamometer (LaFayette Manual Muscle Tester) to measure knee extension of the quadriceps femoris muscle, with three repetitions on each side; measurements will be recorded in Newtons. Peripheral muscle strength will be recorded as Newton (N). |
| Primary | Cardiorespiratory endurance assessment | Before immunotherapy, week 12 and week 24 | Cardiorespiratory endurance will be evaluated via the six minute walk test and total walking distance will be recorded in meters (m). |
| Secondary | Assessment of Quality of Life | Before immunotherapy, week 12 and week 24 | Participants' quality of life will be assessed using the European Organization for Research and Treatment of Cancer to assess health-related quality of life in patients with lung cancer questionnaire (EORTC-QLQ-LC29), which was developed specifically for lung cancer patients by the European Organization for Research, Treatment and Cancer and has been proven to be valid and reliable. Higher scores indicate worse quality of life. The minimum and maximum values are ranged between 0 and 100. |
| Secondary | Fatigue Assessment | Before immunotherapy, week 12 and week 24 | Fatigue will be assessed using the European Organization for Research and Treatment of Cancer to assess fatigue in patients with cancer (EORTC-QLQ-FA12).Higher scores indicate higher perceived fatigue. The minimum and maximum values are ranged between 0 and 100. |
| Secondary | Body fat percentage | Before immunotherapy, week 12 and week 24 | Body fat percentage will be evaluated via Tanita-BC-420 MA. It will be recorded as %(percentage). |
| Secondary | Skeletal Muscle Mass | Before immunotherapy, week 12 and week 24 | Skeletal Muscle Mass will be evaluated via Tanita-BC-420 MA. It will be recorded as kilogram (kg). |
| Secondary | Fat free mass | Before immunotherapy, week 12 and week 24 | Fat free mass will be evaluated via Tanita-BC-420 MA. It will be recorded as kilogram (kg). |
| Secondary | Mental status assessment | Before immunotherapy, week 12 and week 24 | Mental status assessment will be performed via Mini Mental State Examination test. It consists of five domains: orientation (10 points), registration (3 points), attention and calculation (5 points), recall (3 points), and language and visuospatial abilities (9 points). The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Score interpretation is as follows: 24-30 indicates normal cognitive function; 18-23 indicates mild cognitive impairment; 10-17 indicates moderate cognitive impairment; and 0-9 indicates severe cognitive impairment. |
| Secondary | Analysis of Progression-free survival | From enrollment until the end of the 24-month follow-up period | Progression free survival will be performed during the study's timeframe. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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