<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/NCT03237195</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0288</org_study_id>
    <nct_id>NCT03237195</nct_id>
  </id_info>
  <brief_title>Utility and Cost-effectiveness of Microscopic Examination of the Neck Dissection.</brief_title>
  <official_title>Utility and Cost-effectiveness of Microscopic Examination of the Neck Dissection Specimen in Its Entirety.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Mississippi Medical Center</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>
      Most patients with cancer of the head and neck are offered surgical resection of the primary&#xD;
      tumor. In order to determine how the tumor will eventually behave, along with the resection&#xD;
      of the primary tumor, lymph nodes present in the neck are also dissected. Different&#xD;
      institutes have different protocol on handling of the specimen that is received by the&#xD;
      pathology labs after dissection of the neck. The investigators intend to analyze the protocol&#xD;
      that they use to evaluate the neck dissection specimen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a retrospective study. All neck dissections received in the histology laboratory&#xD;
      from Jan 2013 to December 2016 will be retrieved from the histopathology files by conducting&#xD;
      a search through CoPath. The glass slides of all the neck dissections that fit the study&#xD;
      criterion will be retrieved from the archives. The glass slides will be reviewed by the&#xD;
      pathologist.&#xD;
&#xD;
      At the time of review number of lymph nodes identified microscopically, presence or absence&#xD;
      of metastasis and if the Lymph Nodes (LN) were palpable or not palpable will be documented.&#xD;
      The data will be analyzed to see if the submission of extra fat yielded any additional&#xD;
      positive lymph nodes or microscopic deposits. The cost analysis for additional slides will be&#xD;
      also done.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of additional lymph nodes obtained with additional sampling of soft tissue</measure>
    <time_frame>3 years</time_frame>
    <description>Number of additional lymph nodes obtained with additional sampling of soft tissue</description>
  </primary_outcome>
  <enrollment type="Actual">139</enrollment>
  <condition>Metastasis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>additional soft tissue in neck dissections</intervention_name>
    <description>Evaluation of submission of additional soft tissue in neck dissections for head and neck squamous cell carcinomas</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who underwent neck dissection for squamous cell carcinomas of head and neck&#xD;
        origin.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Neck dissection (unilateral and/or bilateral)&#xD;
&#xD;
          2. Primary squamous cell carcinoma of head and neck&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Any neck dissection performed outside UMMC and case received as a consult.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Varsha Manucha</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Gillies EM, Luna MA. Histologic evaluation of neck dissection specimens. Otolaryngol Clin North Am. 1998 Oct;31(5):759-71. doi: 10.1016/s0030-6665(05)70085-2.</citation>
    <PMID>9735105</PMID>
  </results_reference>
  <results_reference>
    <citation>Jose J, Coatesworth AP, MacLennan K. Cervical metastases in upper aerodigestive tract squamous cell carcinoma: histopathologic analysis and reporting. Head Neck. 2003 Mar;25(3):194-7. doi: 10.1002/hed.10194.</citation>
    <PMID>12599286</PMID>
  </results_reference>
  <results_reference>
    <citation>Seethala RR. Current state of neck dissection in the United States. Head Neck Pathol. 2009 Sep;3(3):238-45. doi: 10.1007/s12105-009-0129-y. Epub 2009 Aug 7.</citation>
    <PMID>20596978</PMID>
  </results_reference>
  <results_reference>
    <citation>Muirhead D, Aoun P, Powell M, Juncker F, Mollerup J. Pathology economic model tool: a novel approach to workflow and budget cost analysis in an anatomic pathology laboratory. Arch Pathol Lab Med. 2010 Aug;134(8):1164-9. doi: 10.5858/2000-0401-OA.1.</citation>
    <PMID>20670137</PMID>
  </results_reference>
  <results_reference>
    <citation>van den Brekel MW, Stel HV, van der Valk P, van der Waal I, Meyer CJ, Snow GB. Micrometastases from squamous cell carcinoma in neck dissection specimens. Eur Arch Otorhinolaryngol. 1992;249(6):349-53. doi: 10.1007/BF00179388.</citation>
    <PMID>1384570</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>February 16, 2018</last_update_submitted>
  <last_update_submitted_qc>February 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03237195
org study id: 2016-0288
nct id: NCT03237195
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Most patients with cancer of the head and neck are offered surgical resection of the primary
      tumor. In order to determine how the tumor will eventually behave, along with the resection
      of the primary tumor, lymph nodes present in the neck are also dissected. Different
      institutes have different protocol on handling of the specimen that is received by the
      pathology labs after dissection of the neck. The investigators intend to analyze the protocol
      that they use to evaluate the neck dissection specimen.
This will be a retrospective study. All neck dissections received in the histology laboratory
      from Jan 2013 to December 2016 will be retrieved from the histopathology files by conducting
      a search through CoPath. The glass slides of all the neck dissections that fit the study
      criterion will be retrieved from the archives. The glass slides will be reviewed by the
      pathologist.

      At the time of review number of lymph nodes identified microscopically, presence or absence
      of metastasis and if the Lymph Nodes (LN) were palpable or not palpable will be documented.
      The data will be analyzed to see if the submission of extra fat yielded any additional
      positive lymph nodes or microscopic deposits. The cost analysis for additional slides will be
      also done.
observational model: Case-Crossover
time perspective: Retrospective
measure: Number of additional lymph nodes obtained with additional sampling of soft tissue
time frame: 3 years
description: Number of additional lymph nodes obtained with additional sampling of soft tissue
intervention type: Other
intervention name: additional soft tissue in neck dissections
description: Evaluation of submission of additional soft tissue in neck dissections for head and neck squamous cell carcinomas
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Varsha Manucha
role: Principal Investigator
affiliation: Associate Professor
facility: 
country: United States
citation: Gillies EM, Luna MA. Histologic evaluation of neck dissection specimens. Otolaryngol Clin North Am. 1998 Oct;31(5):759-71. doi: 10.1016/s0030-6665(05)70085-2.
PMID: 9735105
citation: Jose J, Coatesworth AP, MacLennan K. Cervical metastases in upper aerodigestive tract squamous cell carcinoma: histopathologic analysis and reporting. Head Neck. 2003 Mar;25(3):194-7. doi: 10.1002/hed.10194.
PMID: 12599286
citation: Seethala RR. Current state of neck dissection in the United States. Head Neck Pathol. 2009 Sep;3(3):238-45. doi: 10.1007/s12105-009-0129-y. Epub 2009 Aug 7.
PMID: 20596978
citation: Muirhead D, Aoun P, Powell M, Juncker F, Mollerup J. Pathology economic model tool: a novel approach to workflow and budget cost analysis in an anatomic pathology laboratory. Arch Pathol Lab Med. 2010 Aug;134(8):1164-9. doi: 10.5858/2000-0401-OA.1.
PMID: 20670137
citation: van den Brekel MW, Stel HV, van der Valk P, van der Waal I, Meyer CJ, Snow GB. Micrometastases from squamous cell carcinoma in neck dissection specimens. Eur Arch Otorhinolaryngol. 1992;249(6):349-53. doi: 10.1007/BF00179388.
PMID: 1384570
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
sharing ipd: No