Clinical trial NCT06015815: The Association of MicroRNA21-155 Levels With Acute Side Effects In Patients With Stage III NSCLC With Definitive CRT
Official title: The Association of MicroRNA-21 And MicroRNA-155 Levels With Acute Side Effects In Patients With Stage III Non Small Lung Cancer With Definite Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer Stage III
Keywords: Non-Small Cell Lung Cancer
Radiotherapy
MicroRNA-21
MicroRNA-155
Acute Side Effect
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligibility criteria for inclusion in the study were defined as follows: patients aged 18 years or older who are histologically diagnosed with NSCLC and are in stage 3 according to the 8th edition of the American Cancer Committee (AJCC) staging system and are scheduled to receive treatment. During the staging of the patients, all of them underwent thorax computer tomography, positron emissions tomography (PET), and endobronchial ultrasound (EBUS) biopsy and cranial magnetic resonance imaging (MRI).

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine the relationship of miRNA levels with acute side effects of chemoradiotherapy
timeFrame: The participants will be followed for an average of six months, including the period from the beginning of the treatment until three months after the completion of the treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Medicine School Radiation Oncology
Study officials:
affiliation: Ankara University
name: Esra Gümüştepe, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University
name: Serap Akyürek, M.D
role: STUDY_DIRECTOR
References: