Circulating and Molecular Markers Involved in the Processes of Cachexia, Anorexia and Sarcopenia in Patients With NSCLC

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non Small Cell Lung Cancer Anorexia Atrophy Body Weight Body Weight Changes Bronchial Neoplasms Cachexia Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcopenia Signs and Symptoms Signs and Symptoms, Digestive Thinness Thoracic Neoplasms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Study of serum levels of molecules functionally involved in cachexia/anorexia and sarcopenia, markers of inflammation and markers of aging in patients with NSCLC

Time frame: The concentration of the respective molecules between the baseline sample and the sample taken after 3 months of treatment will be compared

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

Flow cytometric analysis of immunosenescence markers in lymphocytes of patients with NSCLC.

Time frame: The percentage of the different subpopulations between the baseline sample and the sample taken after 3 months of treatment will be compared.

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.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study 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).

Acronym: SARCLUNG

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2027
First posted: Feb 5, 2025
Registry last updated: Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed