xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06015815</url>
    </required_header>
    <id_info>
      <org_study_id>SRC Project No: 19L0230007</org_study_id>
      <nct_id>NCT06015815</nct_id>
    </id_info>
    <brief_title>The Association of MicroRNA21-155 Levels With Acute Side Effects In Patients With Stage III NSCLC With Definitive CRT</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ankara University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The present investigation constitutes a prospective cohort study. The objectives encompass&#xD;
        the assessment of miRNA expression levels in total exosomes derived from peripheral&#xD;
        circulation tissues of stage III definite KRT NSCLC patients both at the beginning and&#xD;
        conclusion of their treatment. Furthermore, an exploration is conducted into the potential&#xD;
        correlation existing between alterations in miRNA levels and the incidence of acute&#xD;
        treatment-related side effects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Categorical variables were illustrated using both percentage distributions and numerical&#xD;
        counts, while continuous variables were characterized using the mean accompanied by the&#xD;
        standard deviation, and the median accompanied by the minimum and maximum values. The&#xD;
        assessment of the normality of continuous variables encompassed a combination of visual&#xD;
        methods such as histograms and probability plots, along with analytical tests like the&#xD;
        Kolmogorov-Smirnov and Shapiro-Wilk tests.&#xD;
  &#xD;
        In instances where data exhibited a normal distribution, Student's t-test was utilized for&#xD;
        comparing two groups. For non-normally distributed data, the Mann-Whitney U test was applied.&#xD;
        The comparison of categorical variables between independent groups involved Chi-square and&#xD;
        Fisher's exact tests. Changes within dependent groups were evaluated using the Wilcoxon test.&#xD;
        When performing pairwise comparisons among three or more groups, p-values were calculated&#xD;
        while employing Bonferroni correction.&#xD;
  &#xD;
        For the statistical analysis of the research data, the Statistical Package for Social&#xD;
        Sciences (SPSS) version 25.0 for Windows (SPSS Inc. Chicago, USA) was utilized. The&#xD;
        significance level was set at p&lt;0.05. Additionally, it is important to note that p-values&#xD;
        falling within the range of 0.1 to 0.05 were considered indicative of a statistical trend in&#xD;
        this study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 5, 2019</start_date>
    <completion_date type="Actual">August 15, 2020</completion_date>
    <primary_completion_date type="Actual">April 29, 2020</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To determine the relationship of miRNA levels with acute side effects of chemoradiotherapy</measure>
      <time_frame>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.</time_frame>
      <description>miRNA Expression Measurement: Peripheral blood samples were collected from patients in pre-treatment and post-treatment periods to gauge miRNA expression. Samples were stored under suitable conditions. miRNA-21 and miRNA-155 expression levels were quantified through qRT-PCR. Livak formula-based fold change calculations identified expression shifts from treatment start to end.&#xD;
  Acute Side Effects Assessment:&#xD;
  Acute effects were evaluated as per Cooperative Group Common Toxicity Criteria Acute Side Effects (CTCAE) v5.0. Patients were assessed weekly during treatment and at 1 and 3 months post-treatment, comprehensively analyzing acute effects during treatment.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">21</enrollment>
    <condition>Non-small Cell Lung Cancer Stage III</condition>
    <arm_group>
      <arm_group_label>stage III non-small cell lung cancer</arm_group_label>
      <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</description>
    </arm_group>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        miRNA-21 and miRNA 155 in exosomes were examined in material from peripheral blood.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Eligibility criteria for inclusion in the study were defined as follows: patients aged 18&#xD;
          years or older who are histologically diagnosed with NSCLC and are in stage 3 according to&#xD;
          the 8th edition of the American Cancer Committee (AJCC) staging system and are scheduled to&#xD;
          receive treatment. During the staging of the patients, all of them underwent thorax&#xD;
          computer tomography, positron emissions tomography (PET), and endobronchial ultrasound&#xD;
          (EBUS) biopsy and cranial magnetic resonance imaging (MRI).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient over 18 years old.&#xD;
  &#xD;
            -  To be between 0-2 according to Eastern Cooperative Oncology Group (ECOG) performance&#xD;
               status (PS).&#xD;
  &#xD;
            -  Patient with pathological diagnosis of NSCLC.&#xD;
  &#xD;
            -  Stage 3 Patient&#xD;
  &#xD;
            -  Patient with a definitive chemoradiotherapy (CRT) treatment plan.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with second primary malignancy.&#xD;
  &#xD;
            -  History of previous radiotherapy to the thoracic region&#xD;
  &#xD;
            -  Patient with advanced cardiovascular disease.&#xD;
  &#xD;
            -  Patient with neurological or physical deficit.&#xD;
  &#xD;
            -  Patient with autoimmune disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Esra Gümüştepe, M.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ankara University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Serap Akyürek, M.D</last_name>
      <role>Study Director</role>
      <affiliation>Ankara University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ankara University Medicine School Radiation Oncology</name>
        <address>
          <city>Ankara</city>
          <zip>06590</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ankara University</investigator_affiliation>
      <investigator_full_name>Esra Gümüştepe</investigator_full_name>
      <investigator_title>doctor research assistant</investigator_title>
    </responsible_party>
    <keyword>Non-Small Cell Lung Cancer</keyword>
    <keyword>Radiotherapy</keyword>
    <keyword>MicroRNA-21</keyword>
    <keyword>MicroRNA-155</keyword>
    <keyword>Acute Side Effect</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06015815
  org study id: SRC Project No: 19L0230007
  nct id: NCT06015815
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: To determine the relationship of miRNA levels with acute side effects of chemoradiotherapy
  time frame: 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.
  description: miRNA Expression Measurement: Peripheral blood samples were collected from patients in pre-treatment and post-treatment periods to gauge miRNA expression. Samples were stored under suitable conditions. miRNA-21 and miRNA-155 expression levels were quantified through qRT-PCR. Livak formula-based fold change calculations identified expression shifts from treatment start to end.
  Acute Side Effects Assessment:
  Acute effects were evaluated as per Cooperative Group Common Toxicity Criteria Acute Side Effects (CTCAE) v5.0. Patients were assessed weekly during treatment and at 1 and 3 months post-treatment, comprehensively analyzing acute effects during treatment.
  arm group label: 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
  miRNA-21 and miRNA 155 in exosomes were examined in material from peripheral blood.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  last name: Esra Gümüştepe, M.D
  role: Principal Investigator
  affiliation: Ankara University
  last name: Serap Akyürek, M.D
  role: Study Director
  affiliation: Ankara University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ankara University
  investigator full name: Esra Gümüştepe
  investigator title: doctor research assistant
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  sharing ipd: No