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/NCT06015802</url>
    </required_header>
    <id_info>
      <org_study_id>2021450</org_study_id>
      <nct_id>NCT06015802</nct_id>
    </id_info>
    <brief_title>Predictive Value of Serum and Tissue Molecular Markers and Imaging Features in the Invasiveness and Prognosis of Pituitary Neuroendocrine Tumors</brief_title>
    <official_title>Predictive Value of Serum and Tissue Molecular Markers and Imaging Features in the Invasiveness and Prognosis of Pituitary Neuroendocrine Tumors</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        As the clinical manifestations of pituitary neuroendocrine tumors vary greatly, 2.7-15% of&#xD;
        them are resistant to conventional treatments such as surgery, drug therapy and radiotherapy,&#xD;
        and often relapse or regrow in the early postoperative period, which is invasive and has a&#xD;
        poor prognosis. Therefore, it is important to find imaging, histological or serum molecular&#xD;
        markers for early prediction of the invasiveness and clinical prognosis of pituitary&#xD;
        neuroendocrine tumors. The aim of this study is to observe the changes of biomarkers and&#xD;
        imaging features in serum or tissues of pituitary neuroendocrine tumors during the course of&#xD;
        disease and treatment, and to explore the biomarkers and imaging features that can predict&#xD;
        the proliferation, progression and recurrence risk of pituitary neuroendocrine tumors after&#xD;
        medical or surgical treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2021</start_date>
    <completion_date type="Anticipated">March 2029</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>Disease progression or recurrence after surgery</measure>
      <time_frame>up to 5 years</time_frame>
      <description>Disease'recurrence'corresponded to tumour detection at MRI and/or hormone hypersecretion in previously cured patients, while disease'progression'indicated the increase in size of post-operative tumour remnant in nonfunctioning tumours and/or relapse of hormone hypersecretion in functioning ones</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Pituitary Adenoma</condition>
    <condition>Neuroendocrine Tumors</condition>
    <arm_group>
      <arm_group_label>Pituitary neuroendocrine tumors</arm_group_label>
      <description>Patients with pituitary neuroendocrine tumors: pituitary adenoma was diagnosed by clinical imaging, with or without pituitary hormone secretion function was confirmed by pituitary hormone detection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>diagnosed and treated reasonably according to the clinical guidelines and clinical pathways</intervention_name>
      <description>The clinical data and biological specimens of the selected patients were collected, and the patients were diagnosed and treated reasonably according to the clinical guidelines and clinical pathways. The prognosis and outcome of the disease within 5 years after discharge were observed.</description>
      <arm_group_label>Pituitary neuroendocrine tumors</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with pituitary neuroendocrine tumors: pituitary adenoma was diagnosed by clinical&#xD;
          imaging, with or without pituitary hormone secretion function was confirmed by pituitary&#xD;
          hormone detection.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients with pituitary neuroendocrine tumors: pituitary adenoma was diagnosed by clinical&#xD;
          imaging, with or without pituitary hormone secretion function was confirmed by pituitary&#xD;
          hormone detection.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous pathological specimen suggested pituitary carcinoma.&#xD;
  &#xD;
            2. always have received radiation and chemotherapy or immune and targeted therapy of the&#xD;
               patients.&#xD;
  &#xD;
            3. with known genetic syndrome can cause excessive secretion of hormones (such as Carney&#xD;
               syndrome, McCune - Albright syndrome, multiple endocrine neoplasia type 1, acute&#xD;
               interstitial pneumonia) patients.&#xD;
  &#xD;
            4. there are ectopic neuroendocrine tumor patients.&#xD;
  &#xD;
            5. within one month before the screening for major surgery, or within 3 months before&#xD;
               screening for patients with sphenoid pituitary surgery.&#xD;
  &#xD;
            6. crisis of gland function (the pituitary gland, thyroid crisis, adrenal crisis).&#xD;
  &#xD;
            7. peripheral glands or other solid tumors in patients with severe disease or blood&#xD;
               system.&#xD;
  &#xD;
            8. serious organ damage such as heart, kidney, liver, etc.&#xD;
  &#xD;
            9. with severe mental or nervous system disease.&#xD;
  &#xD;
           10. serious high blood glucose or poorly controlled hypertension or emergency patients.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>endocrinology department of the first affiliated hospital of Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510080</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yanbing Li, MD,PhD</last_name>
        <phone>8602087334331</phone>
        <email>easd04lyb@126.com</email>
      </contact>
      <investigator>
        <last_name>Yanbing Li, MD,PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 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>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Yanbing Li</investigator_full_name>
      <investigator_title>director of endocrinology department</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenoma</mesh_term>
      <mesh_term>Neuroendocrine Tumors</mesh_term>
      <mesh_term>Pituitary Neoplasms</mesh_term>
      <mesh_term>Pituitary Diseases</mesh_term>
    </condition_browse>
    <!-- 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/NCT06015802
  org study id: 2021450
  nct id: NCT06015802
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  As the clinical manifestations of pituitary neuroendocrine tumors vary greatly, 2.7-15% of
        them are resistant to conventional treatments such as surgery, drug therapy and radiotherapy,
        and often relapse or regrow in the early postoperative period, which is invasive and has a
        poor prognosis. Therefore, it is important to find imaging, histological or serum molecular
        markers for early prediction of the invasiveness and clinical prognosis of pituitary
        neuroendocrine tumors. The aim of this study is to observe the changes of biomarkers and
        imaging features in serum or tissues of pituitary neuroendocrine tumors during the course of
        disease and treatment, and to explore the biomarkers and imaging features that can predict
        the proliferation, progression and recurrence risk of pituitary neuroendocrine tumors after
        medical or surgical treatment.
  observational model: Cohort
  time perspective: Prospective
  measure: Disease progression or recurrence after surgery
  time frame: up to 5 years
  description: Disease'recurrence'corresponded to tumour detection at MRI and/or hormone hypersecretion in previously cured patients, while disease'progression'indicated the increase in size of post-operative tumour remnant in nonfunctioning tumours and/or relapse of hormone hypersecretion in functioning ones
  arm group label: Pituitary neuroendocrine tumors
  description: Patients with pituitary neuroendocrine tumors: pituitary adenoma was diagnosed by clinical imaging, with or without pituitary hormone secretion function was confirmed by pituitary hormone detection.
  intervention type: Other
  intervention name: diagnosed and treated reasonably according to the clinical guidelines and clinical pathways
  description: The clinical data and biological specimens of the selected patients were collected, and the patients were diagnosed and treated reasonably according to the clinical guidelines and clinical pathways. The prognosis and outcome of the disease within 5 years after discharge were observed.
  arm group label: Pituitary neuroendocrine tumors
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Yanbing Li
  investigator title: director of endocrinology department
  mesh term: Adenoma
  mesh term: Neuroendocrine Tumors
  mesh term: Pituitary Neoplasms
  mesh term: Pituitary Diseases