Clinical trial · Observational
Circulating and Molecular Markers Involved in the Processes of Cachexia, Anorexia and Sarcopenia in Patients With NSCLC
Study of Circulating and Molecular Markers Functionally Involved in the Processes of Cachexia, Anorexia and Sarcopenia in Patients With Advanced Non-small Cell Lung Cancer (NSCLC).
NCT06808113CI-TRIAL-00085555SARCLUNGactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study aim to evaluate whether some substances produced by muscle or adipose tissue may play a role in the course of the disease by interfering with the effectiveness of therapies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Study of serum levels of molecules functionally involved in cachexia/anorexia and sarcopenia, markers of inflammation and markers of aging in patients with NSCLC
- timeFrame
- The concentration of the respective molecules between the baseline sample and the sample taken after 3 months of treatment will be compared
- description
- To determine the plasma levels of GDF15, FGF21, some microRNAs involved in inflammatory processes called inflammamiR and to perform the measurement of telomere length in leukocytes in plasma samples of patients with NSCLC before and after treatment with chemotherapy and immunotherapy or immunotherapy alone. The association between variables of clinical interest and plasma levels of the aforementioned molecules will be evaluated. In particular, the association between their plasma levels and body composition expressed as a percentage of fat mass and lean mass and overall-survival (OS) and progression-free survival (PFS) will be evaluated.
Secondary outcomes (1)
- measure
- Flow cytometric analysis of immunosenescence markers in lymphocytes of patients with NSCLC.
- timeFrame
- The percentage of the different subpopulations between the baseline sample and the sample taken after 3 months of treatment will be compared.
- description
- The leukocyte subpopulations of interest (cell. T naïve, cell. T of the central memory, cell. T of effector memory, cell. Suppressive Myeloids, cell. NK) will be reported as percentages per sample. The association between variables of clinical interest and the percentage of different leukocyte subpopulations will be evaluated. The association between percentages of white blood cell subpopulations and OS, PFS will be evaluated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with NSCLC in advanced stage (IIIB, IV) * Patients eligible for the treatment with single-agent immunotherapy (Pembrolizumab), or a chemo-immunotherapy combination among the approved ones for I line * Obtainment of the informations related to medical history and the possibility to have an adequate follow up * Obtainment of the informed consent * Age ≥ 18 years Exclusion Criteria: * Patients with psychiatric alterations, neurological diseases or other condistions that could not allow adhesion to study protocol and the obtainment of the ICF
References
Publications (0)
Data not yet available
No reference posted for this study.