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/NCT06034782</url>
    </required_header>
    <id_info>
      <org_study_id>18/22-02-2021</org_study_id>
      <nct_id>NCT06034782</nct_id>
    </id_info>
    <brief_title>Diagnostic Accuracy of Fine Needle Aspiration in Patients With Salivary Gland Tumors.</brief_title>
    <official_title>Diagnostic Accuracy of Fine Needle Aspiration in Patients With Salivary Gland Tumors,a Retrospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aristotle University Of Thessaloniki</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aristotle University Of Thessaloniki</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Tumors of the salivary glands occupy 0.5-1.2% of cases of head and neck tumors. They are&#xD;
        primarily a surgical disease, as their treatment is basically the surgical excision. In this&#xD;
        direction and in the context of the differential preoperative diagnosis, in addition to the&#xD;
        imaging methods, the fine needle biopsy (FNA) was used, with which cell material is aspirated&#xD;
        from the tumor and studied under the microscope. Although an increasing number of papers have&#xD;
        been published in the international scientific literature over the last 5 years on the&#xD;
        diagnostic accuracy of FNA in salivary glands, many of them are unable to quantify and omit&#xD;
        to refer information that could affect the estimated diagnostic accuracy. Such information is&#xD;
        for instance the clinical experience of the doctor who performs the FNA and of the one who&#xD;
        assess the smear. The aim of this retrospective study is to evaluate the diagnostic accuracy&#xD;
        of fine needle biopsy in adult patients with salivary gland tumor that underwent a surgical&#xD;
        excision in two Oral and Maxillofacial Departments in Northern Greece.&#xD;
  &#xD;
        The present retrospective study was carried out from 2/2021 to 4/2022 by collecting data from&#xD;
        the files of patients who underwent surgery at the Oral and Maxillofacial Clinic of the&#xD;
        Theageneio Cancer Hospital of Thessaloniki 1996-2022 and the General Hospital of Thessaloniki&#xD;
        G. Papanikolaou 2015-2022. The study was conducted according to the STARD 2015 protocol.&#xD;
  &#xD;
        FNA contributed significantly to the differential preoperative process in salivary gland&#xD;
        diseases. The differential diagnosis of a lesion in benign / malignant preoperatively, with&#xD;
        the use of FNA, enables the surgeon for a more beneficial to the patient and oncologically&#xD;
        safer planning of the surgery. It is considered important the high sensitivity provided by&#xD;
        the examination, as it helps to exclude with sufficient safety the possible malignancy of the&#xD;
        tumor located in the salivary gland of the patient.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This retrospective study was conducted according to the STARD 2015 protocol. A thorough&#xD;
        retrospective analysis of patient data that were extracted from patient records of a tertiary&#xD;
        referral hospital database was performed. The patient files which were included in the study&#xD;
        are electronically archived at the Departments of Oral and Maxillofacial Surgery of&#xD;
        &quot;Theageneio Anti-Cancer Hospital of Thessaloniki&quot; and of General Hospital of Thessaloniki&#xD;
        &quot;George Papanikolaou&quot;.&#xD;
  &#xD;
        Patients who were included in the present study, except for clinical examination by an Oral&#xD;
        and Maxillofacial Surgeon, also underwent at least one imaging modality (MRI, CT scan,&#xD;
        ultrasound scan).&#xD;
  &#xD;
        This retrospective study was carried out from 2/2021 to 4/2022. Data from records of patients&#xD;
        who underwent salivary tumour surgery at the Oral and Maxillofacial Surgery departments of&#xD;
        Theageneio Anti-Cancer Hospital of Thessaloniki 1996-2022 and of the General Hospital of&#xD;
        Thessaloniki G. Papanikolaou 2015-2022 were collected.&#xD;
  &#xD;
        The surgical treatment of all patients with salivary gland tumors who were examined by a&#xD;
        practitioner of the two aforementioned Maxillofacial departments, was based on their&#xD;
        chronological attendance at the outpatient clinic, while there was no attempt of grouping of&#xD;
        them.&#xD;
  &#xD;
        Based on the FNA report, FNA results were categorized as follows: Benign, Malignant,&#xD;
        Non-diagnostic, Unavailable result. The same categories were obtained for the reference&#xD;
        standard test, which was the histopathological examination of the resected tumor.&#xD;
  &#xD;
        The sample size was calculated using the software G power analysis version 3.1.9.6. For α =&#xD;
        0.05 and study strength Power 0.95 a sample size of 102 patients had been obtained which was&#xD;
        relatively smaller compared to the 128 patients that were finally included in the study.&#xD;
  &#xD;
        During the data collection from the medical patient records, there were 11 (n = 11) out of&#xD;
        139 (n = 139) cases whose FNA result and 4 (n=4) out of 184 (n=184) whose histological result&#xD;
        was non-diagnostic as it was not clearly concluded whether the lesion was benign or&#xD;
        malignant. These cases were excluded from the estimation of diagnostic accuracy indicators.&#xD;
        Likewise to the non-diagnostic results, were excluded the 145 (n = 145) FNA results that were&#xD;
        not available.&#xD;
  &#xD;
        To assess the diagnostic accuracy of FNA, a comparative process among FNA and&#xD;
        histopathological outcomes was conducted. Sensitivity, specificity, positive predictive&#xD;
        value, negative predictive value, positive likelihood ratio, negative likelihood ratio, ROC&#xD;
        curve and AUC (Area Under curve) were calculated. Calculations were made using software&#xD;
        RStudio Version 1.4.1106 © 2009-2021 RStudio, PBC &quot;Tiger Daylily&quot; (2389bc24, 2021-02-11) for&#xD;
        Windows Mozilla/5.0 (Windows NT 10.0; Win64; x64) Apple Web Kit/537.36 (KHTML, like Gecko) Qt&#xD;
        Web Engine/5.12.8 Chrome/69.0.3497.128 Safari/537.36.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 22, 2021</start_date>
    <completion_date type="Actual">June 6, 2022</completion_date>
    <primary_completion_date type="Actual">May 15, 2022</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Diagnostic accuracy of Fine Needle Aspiration in salivary tumors</measure>
      <time_frame>Every patient underwent FNA in a time frame from 1 day to 1 month before the surgical resection of the tumor. Then, under general anesthesia the tumor was surgicaly resected and was immediately examined to the Histology Laboratory of the Hospital.</time_frame>
      <description>The result FNA of salivary tumor was compared to (verified) Histologic result after tumor resection. Then Diagnostic accuracy of FNA was estimated.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">128</enrollment>
    <condition>Salivary Gland Tumor</condition>
    <condition>Diagnosis</condition>
    <arm_group>
      <arm_group_label>patients with salivary gland tumors</arm_group_label>
      <description>patients with salivary gland tumors</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Fine Needle Aspiration</intervention_name>
      <description>Fine Needle Aspiration of a salivary gland tumor</description>
      <arm_group_label>patients with salivary gland tumors</arm_group_label>
      <other_name>FNA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Histologic Examination</intervention_name>
      <description>Histologic examination of resected salivary tumor</description>
      <arm_group_label>patients with salivary gland tumors</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients with salivary tumors that examined in outpatient Oral and Maxillofacial&#xD;
          Surgery Clinic of Anti-Cancer Hospital of Thessaloniki &quot;Theageneio&quot; and General Hospital of&#xD;
          Thessaloniki &quot;G. Papanikolaou&quot;.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients &gt;=18 years&#xD;
  &#xD;
            -  salivary tumor suspected&#xD;
  &#xD;
            -  FNA result available&#xD;
  &#xD;
            -  Salivary tumor surgically resected&#xD;
  &#xD;
            -  Histologic result available&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients under 18 years old&#xD;
  &#xD;
            -  FNA result or Histologic result not available&#xD;
  &#xD;
            -  No tumor resection&#xD;
  &#xD;
            -  Other neck tumors (not salivary tumor)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>24 Years</minimum_age>
      <maximum_age>96 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Theodoros V. Grivas, Medical</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aristotle University Thessaloniki</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Aristotle University</name>
        <address>
          <city>Thessaloníki</city>
          <zip>54124</zip>
          <country>Greece</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Greece</country>
    </location_countries>
    <verification_date>August 2022</verification_date>
    <study_first_submitted>August 19, 2022</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>salivary tumors</keyword>
    <keyword>diagnostic accuracy</keyword>
    <keyword>Fine Needle Aspiration</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Salivary Gland Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>SN,Sex,Clinic of Origin,Date of Birth,Age, Final Result of FNA (as included in Excel database),Histological result (as included in Excel database) are available to all researchers.</ipd_description>
      <ipd_time_frame>Immediatelly available and for 6 months</ipd_time_frame>
      <ipd_access_criteria>The excel database with the menioned individual participant data (IPD) can be available only for academical reason after email verification</ipd_access_criteria>
    </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/NCT06034782
  org study id: 18/22-02-2021
  nct id: NCT06034782
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Tumors of the salivary glands occupy 0.5-1.2% of cases of head and neck tumors. They are
        primarily a surgical disease, as their treatment is basically the surgical excision. In this
        direction and in the context of the differential preoperative diagnosis, in addition to the
        imaging methods, the fine needle biopsy (FNA) was used, with which cell material is aspirated
        from the tumor and studied under the microscope. Although an increasing number of papers have
        been published in the international scientific literature over the last 5 years on the
        diagnostic accuracy of FNA in salivary glands, many of them are unable to quantify and omit
        to refer information that could affect the estimated diagnostic accuracy. Such information is
        for instance the clinical experience of the doctor who performs the FNA and of the one who
        assess the smear. The aim of this retrospective study is to evaluate the diagnostic accuracy
        of fine needle biopsy in adult patients with salivary gland tumor that underwent a surgical
        excision in two Oral and Maxillofacial Departments in Northern Greece.
  
        The present retrospective study was carried out from 2/2021 to 4/2022 by collecting data from
        the files of patients who underwent surgery at the Oral and Maxillofacial Clinic of the
        Theageneio Cancer Hospital of Thessaloniki 1996-2022 and the General Hospital of Thessaloniki
        G. Papanikolaou 2015-2022. The study was conducted according to the STARD 2015 protocol.
  
        FNA contributed significantly to the differential preoperative process in salivary gland
        diseases. The differential diagnosis of a lesion in benign / malignant preoperatively, with
        the use of FNA, enables the surgeon for a more beneficial to the patient and oncologically
        safer planning of the surgery. It is considered important the high sensitivity provided by
        the examination, as it helps to exclude with sufficient safety the possible malignancy of the
        tumor located in the salivary gland of the patient.
  This retrospective study was conducted according to the STARD 2015 protocol. A thorough
        retrospective analysis of patient data that were extracted from patient records of a tertiary
        referral hospital database was performed. The patient files which were included in the study
        are electronically archived at the Departments of Oral and Maxillofacial Surgery of
        "Theageneio Anti-Cancer Hospital of Thessaloniki" and of General Hospital of Thessaloniki
        "George Papanikolaou".
  
        Patients who were included in the present study, except for clinical examination by an Oral
        and Maxillofacial Surgeon, also underwent at least one imaging modality (MRI, CT scan,
        ultrasound scan).
  
        This retrospective study was carried out from 2/2021 to 4/2022. Data from records of patients
        who underwent salivary tumour surgery at the Oral and Maxillofacial Surgery departments of
        Theageneio Anti-Cancer Hospital of Thessaloniki 1996-2022 and of the General Hospital of
        Thessaloniki G. Papanikolaou 2015-2022 were collected.
  
        The surgical treatment of all patients with salivary gland tumors who were examined by a
        practitioner of the two aforementioned Maxillofacial departments, was based on their
        chronological attendance at the outpatient clinic, while there was no attempt of grouping of
        them.
  
        Based on the FNA report, FNA results were categorized as follows: Benign, Malignant,
        Non-diagnostic, Unavailable result. The same categories were obtained for the reference
        standard test, which was the histopathological examination of the resected tumor.
  
        The sample size was calculated using the software G power analysis version 3.1.9.6. For α =
        0.05 and study strength Power 0.95 a sample size of 102 patients had been obtained which was
        relatively smaller compared to the 128 patients that were finally included in the study.
  
        During the data collection from the medical patient records, there were 11 (n = 11) out of
        139 (n = 139) cases whose FNA result and 4 (n=4) out of 184 (n=184) whose histological result
        was non-diagnostic as it was not clearly concluded whether the lesion was benign or
        malignant. These cases were excluded from the estimation of diagnostic accuracy indicators.
        Likewise to the non-diagnostic results, were excluded the 145 (n = 145) FNA results that were
        not available.
  
        To assess the diagnostic accuracy of FNA, a comparative process among FNA and
        histopathological outcomes was conducted. Sensitivity, specificity, positive predictive
        value, negative predictive value, positive likelihood ratio, negative likelihood ratio, ROC
        curve and AUC (Area Under curve) were calculated. Calculations were made using software
        RStudio Version 1.4.1106 © 2009-2021 RStudio, PBC "Tiger Daylily" (2389bc24, 2021-02-11) for
        Windows Mozilla/5.0 (Windows NT 10.0; Win64; x64) Apple Web Kit/537.36 (KHTML, like Gecko) Qt
        Web Engine/5.12.8 Chrome/69.0.3497.128 Safari/537.36.
  observational model: Other
  time perspective: Other
  measure: Diagnostic accuracy of Fine Needle Aspiration in salivary tumors
  time frame: Every patient underwent FNA in a time frame from 1 day to 1 month before the surgical resection of the tumor. Then, under general anesthesia the tumor was surgicaly resected and was immediately examined to the Histology Laboratory of the Hospital.
  description: The result FNA of salivary tumor was compared to (verified) Histologic result after tumor resection. Then Diagnostic accuracy of FNA was estimated.
  arm group label: patients with salivary gland tumors
  description: patients with salivary gland tumors
  intervention type: Diagnostic Test
  intervention name: Fine Needle Aspiration
  description: Fine Needle Aspiration of a salivary gland tumor
  arm group label: patients with salivary gland tumors
  other name: FNA
  intervention type: Procedure
  intervention name: Histologic Examination
  description: Histologic examination of resected salivary tumor
  arm group label: patients with salivary gland tumors
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 24 Years
  maximum age: 96 Years
  healthy volunteers: No
  last name: Theodoros V. Grivas, Medical
  role: Principal Investigator
  affiliation: Aristotle University Thessaloniki
  facility: 
  country: Greece
  responsible party type: Sponsor
  mesh term: Salivary Gland Neoplasms
  sharing ipd: Yes
  ipd description: SN,Sex,Clinic of Origin,Date of Birth,Age, Final Result of FNA (as included in Excel database),Histological result (as included in Excel database) are available to all researchers.
  ipd time frame: Immediatelly available and for 6 months
  ipd access criteria: The excel database with the menioned individual participant data (IPD) can be available only for academical reason after email verification