Clinical trial NCT06808113: Circulating and Molecular Markers Involved in the Processes of Cachexia, Anorexia and Sarcopenia in Patients With NSCLC
Official title: 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).
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non Small Cell Lung Cancer
Keywords: non small cell lung cancer
sarcopenia
cachexia
anorexia
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with NSCLC diagnosis in advanced stage, who are eligibble to receive a treatment with single-agent immunotherapy, or a chemo-immunotherapy combination

Brief summary: 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.

Detailed description: The study is aimed at patients with NSCLC in whom plasma levels of particular biomarkers will be studied before and after treatment with chemotherapy and immunotherapy or immunotherapy alone.

In particular, the plasma levels of GDF15, FGF21, HN, Activin molecules and microRNAs involved in inflammatory processes, called inflammamiR, in particular of microRNA146, 126, 21, 188, 155, will be studied.

Assessments of cellular markers of leukocyte aging will also be performed (determination of telomere length is a widely used measure of biological aging)

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
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.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Andrea Ardizzoni, MD
role: PRINCIPAL_INVESTIGATOR
References: