The Association of MicroRNA21-155 Levels With Acute Side Effects In Patients With Stage III NSCLC With Definitive CRT

Ankara University

Status: Completed

Conditions: Non-small Cell Lung Cancer Stage III

Study type: Observational

Funder types: Other

Identifiers

NCT06015815

SRC Project No: 19L0230007

Details and patient eligibility

About

The present investigation constitutes a prospective cohort study. The objectives encompass the assessment of miRNA expression levels in total exosomes derived from peripheral circulation tissues of stage III definite KRT NSCLC patients both at the beginning and conclusion of their treatment. Furthermore, an exploration is conducted into the potential correlation existing between alterations in miRNA levels and the incidence of acute treatment-related side effects.

Full description

Categorical variables were illustrated using both percentage distributions and numerical counts, while continuous variables were characterized using the mean accompanied by the standard deviation, and the median accompanied by the minimum and maximum values. The assessment of the normality of continuous variables encompassed a combination of visual methods such as histograms and probability plots, along with analytical tests like the Kolmogorov-Smirnov and Shapiro-Wilk tests.

In instances where data exhibited a normal distribution, Student's t-test was utilized for comparing two groups. For non-normally distributed data, the Mann-Whitney U test was applied. The comparison of categorical variables between independent groups involved Chi-square and Fisher's exact tests. Changes within dependent groups were evaluated using the Wilcoxon test. When performing pairwise comparisons among three or more groups, p-values were calculated while employing Bonferroni correction.

For the statistical analysis of the research data, the Statistical Package for Social Sciences (SPSS) version 25.0 for Windows (SPSS Inc. Chicago, USA) was utilized. The significance level was set at p<0.05. Additionally, it is important to note that p-values falling within the range of 0.1 to 0.05 were considered indicative of a statistical trend in this study.

Enrollment: 21 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient over 18 years old.
• To be between 0-2 according to Eastern Cooperative Oncology Group (ECOG) performance status (PS).
• Patient with pathological diagnosis of NSCLC.
• Stage 3 Patient
• Patient with a definitive chemoradiotherapy (CRT) treatment plan.

Exclusion criteria

• Patient with second primary malignancy.
• History of previous radiotherapy to the thoracic region
• Patient with advanced cardiovascular disease.
• Patient with neurological or physical deficit.
• Patient with autoimmune disease

Trial design

21 participants in 1 patient group

stage III non-small cell lung cancer

Description:

A total of 21 patients with stage III NSCLC who received definitive CRT were prospectively evaluated. The expression levels of miRNA-21 and miRNA-155 in serum at the beginning and end of the treatment