<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/NCT03006588</url>
  </required_header>
  <id_info>
    <org_study_id>EUS-FNA for RPLN(2016)</org_study_id>
    <nct_id>NCT03006588</nct_id>
  </id_info>
  <brief_title>EUS-FNA for Retropharyngeal Lymph Node (RPLN) in Recurrent Nasopharyngeal Carcinoma (NPC) Patients</brief_title>
  <official_title>Fine Needle Aspiration of Retropharyngeal Lymph Node Guided by Endoscopic Ultrasound for the Diagnosis of Patients With Suspected Recurrent Nasopharyngeal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      EUS-FNA for RPLN in NPC&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the safety and efficacy of a novel minimally invasive sampling technique -- fine&#xD;
      needle aspiration (FNA) guided by endoscopic ultrasound (EUS), which aims to sample tissues&#xD;
      from retropharyngeal lymph nodes (RPLN) for the diagnosis of patients with suspected&#xD;
      recurrent nasopharyngeal carcinoma (NPC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Number of participants with cancer positive and negative</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>EUS-FNA for RPLN in NPC patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fine needle aspiration guided by EUS in retropharyngeal lymph node in suspicious recurrent naspharyngeal carcinoma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>EUS-FNA for RPLN in NPC patients</intervention_name>
    <description>An EUS probe was introduced to nasopharynx and the retropharyngeal space (RPS) were scanned. The suspicious recurrent RPLN, which was characterized as (1) roughly round and homogeneously hypo-echoic lesion in RPS; (2) located anterior to the carotid sheath which contained the internal carotid artery (ICA) and the internal jugular vein (IJV). Subsequently, guiding by EUS, a dedicated 22G needle was used to puncture into the enlarged RPLN, then the aspiration was conducted The entire EUS-FNA procedure was repeated at least three times till the satisfied strip tissue was obtained. The obtained tissue samples were sent for pathologic detection and the supernatant fluid was for thinprep cytologic test (TCT).</description>
    <arm_group_label>EUS-FNA for RPLN in NPC patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. had undifferentiated, non-keratinizing carcinoma at the initial diagnosis (WHO, 1991&#xD;
             criteria) and no evidence of distant metastasis obtained before radiotherapy;&#xD;
&#xD;
          2. received regular chemotherapy with cytotoxic agents such as cisplatin, carboplatin,&#xD;
             5-fluorouracil, paclitaxel, etc, and coordinated with radiotherapy with standard doses&#xD;
             (approximate 50-70 Gy) in nasopharynx and neck respectively. Within 3 months after&#xD;
             radiotherapy, no local and distant lesions were found;&#xD;
&#xD;
          3. during regular follow-up , the enlarged RPLN was detected by MRI more than 6 months&#xD;
             later since radiotherapy accomplished;&#xD;
&#xD;
          4. didn't receive chemotherapy radiotherapy, immunotherapy or salvage surgery from&#xD;
             completion of radiotherapy to suspicious recurrent lesion in RPLN detected;&#xD;
&#xD;
          5. no recurrent lesion in nasopharynx was found by white light endoscopy as well as&#xD;
             cancer cell negative in pathology by bite biopsy;&#xD;
&#xD;
          6. single lesion in RPLN, and no other recurrent or metastatic lesion was found in local&#xD;
             region or distant organ.&#xD;
&#xD;
          7. the minimum axial diameter of RPLN was more than 5mm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) patients with nasal stenosis; (2) patients with coagulation dysfunction; (3)&#xD;
             patients with distant metastasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jian-jun Li, MD &amp; Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jian-jun Li, MD &amp; Ph.D</last_name>
    <phone>+862087342822</phone>
    <email>lijj@sysucc.org.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xin-xi Zhou, MD</last_name>
    <phone>+862087343135</phone>
    <email>zhouxx@sysucc.org.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xin-xi Zhou, MD</last_name>
      <phone>+862087343135</phone>
      <email>zhouxx@sysucc.org.cn</email>
    </contact>
    <investigator>
      <last_name>Jian-jun Li, MD &amp; PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Jian-jun Li</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>FNA,EUS,retropharyngeal lymph node (RPLN),NPC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</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/NCT03006588
org study id: EUS-FNA for RPLN(2016)
nct id: NCT03006588
lead sponsor: 
has dmc: Yes
EUS-FNA for RPLN in NPC
To evaluate the safety and efficacy of a novel minimally invasive sampling technique -- fine
      needle aspiration (FNA) guided by endoscopic ultrasound (EUS), which aims to sample tissues
      from retropharyngeal lymph nodes (RPLN) for the diagnosis of patients with suspected
      recurrent nasopharyngeal carcinoma (NPC).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Accuracy
time frame: Up to 24 weeks
description: Number of participants with cancer positive and negative
arm group label: EUS-FNA for RPLN in NPC patients
arm group type: Experimental
description: Fine needle aspiration guided by EUS in retropharyngeal lymph node in suspicious recurrent naspharyngeal carcinoma.
intervention type: Procedure
intervention name: EUS-FNA for RPLN in NPC patients
description: An EUS probe was introduced to nasopharynx and the retropharyngeal space (RPS) were scanned. The suspicious recurrent RPLN, which was characterized as (1) roughly round and homogeneously hypo-echoic lesion in RPS; (2) located anterior to the carotid sheath which contained the internal carotid artery (ICA) and the internal jugular vein (IJV). Subsequently, guiding by EUS, a dedicated 22G needle was used to puncture into the enlarged RPLN, then the aspiration was conducted The entire EUS-FNA procedure was repeated at least three times till the satisfied strip tissue was obtained. The obtained tissue samples were sent for pathologic detection and the supernatant fluid was for thinprep cytologic test (TCT).
arm group label: EUS-FNA for RPLN in NPC patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jian-jun Li, MD & Ph.D
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: Jian-jun Li, MD & Ph.D
phone: +862087342822
email: lijj@sysucc.org.cn
last name: Xin-xi Zhou, MD
phone: +862087343135
email: zhouxx@sysucc.org.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Jian-jun Li
investigator title: Associate Professor
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
sharing ipd: No