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

NCT06808113 | Active Not Recruiting

• 2 other identifiers: SARCLUNG2021.0156
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

non small cell lung cancer; sarcopenia; cachexia; anorexia

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (1)

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients with psychiatric alterations, neurological diseases or other condistions that could not allow adhesion to study protocol and the obtainment of the ICF

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Sarcopenia; Cachexia; Anorexia

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Thinness; Signs and Symptoms, Digestive

Study Officials

• Andrea Ardizzoni, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: November 7, 2022
• Primary Completion: October 7, 2024
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 5, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)