<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/NCT03812939</url>
  </required_header>
  <id_info>
    <org_study_id>ZS-1788</org_study_id>
    <nct_id>NCT03812939</nct_id>
  </id_info>
  <brief_title>Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs</brief_title>
  <official_title>An Observational Study Investigating Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type&#xD;
      I gastric neuroendocrine tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Recurrence rate</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in clinical symptoms</measure>
    <time_frame>6 months to 1 year</time_frame>
    <description>Measured by a questionnaire, including whether the patient presents with dyspepsia, abdominal pain, cramps, bloating, nausea, vomiting, lack of appetite, facial flushing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of serum Gastrin</measure>
    <time_frame>6 months to 1 year</time_frame>
    <description>Concentration of serum Gastrin after 12 hours of fasting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enterochromaffin-like cell (ECL) status</measure>
    <time_frame>6 months to 1 year</time_frame>
    <description>Normal Hyperplasia: ECL cell proliferation with a diameter &lt;150 μm, distinguished in: normal pattern/simple hyperplasia, linear, micronodular and adenomatoid hyperplasia.&#xD;
Dysplasia: ECL cell proliferation &gt;150 but &lt;500 μm. Type I gastric carcinoid: ECL proliferation &gt;500 μm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of side-effects of Octreotide</measure>
    <time_frame>6 months to 1 year</time_frame>
    <description>Measured by a questionnaire for patients and clinician's report. Including: hypersensitivity, endocrine disorders (abnormal thyroid functions), metabolism and nutrition disorders (abnormal blood glucose), headache, bradycardia or tachycardia, dyspnea, gastrointestinal disorders (diarrhea, abdominal pain, nausea, constipation, flatulence), hepatobiliary disorders, skin disorders, injection site reaction.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Gastric NET</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Octreotide</intervention_name>
    <description>Patients will receive 6-12 monthly injections every 28 (+/- 3) days.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Type I gastric NET patients from tertiary medical center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologic diagnosis of gastric neuroendocrine tumor.&#xD;
&#xD;
          -  Clinical diagnosis of Type I gastric NET: neuroendocrine tumor arising from atrophic&#xD;
             body gastritis (ABG diagnosis should be based on hypergastrinemia and histological&#xD;
             confirmation of gastric body atrophy on multiple biopsies performed in gastric antrum&#xD;
             and body).&#xD;
&#xD;
          -  Previous esophagogastroduodenoscopy: all visible NETs resected with R0 margin,&#xD;
             confirmed no visible gastric NETs left, multiple biopsies taken to evaluate gastric&#xD;
             atrophy and ECL status.&#xD;
&#xD;
          -  No tumor metastases confirmed by endoscopic ultrasonography, CT scan or somatostatin&#xD;
             receptor scintigraphy.&#xD;
&#xD;
          -  SSA therapy is recommended by physician for disease management, and has not yet begun.&#xD;
&#xD;
          -  Written informed consent obtained prior to treatment to be consistent with local&#xD;
             regulatory requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pathological grading as G3 NET (Ki-67&gt;20%).&#xD;
&#xD;
          -  Patients with a known hypersensitivity to somatostatin analogs.&#xD;
&#xD;
          -  Known gallbladder or bile duct disease, acute or chronic pancreatitis.&#xD;
&#xD;
          -  Known medical condition related with prolonged QT interval.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Patients with serious complicated infections, or nonmalignant medical illnesses that&#xD;
             are uncontrolled or whose control may be jeopardized by the complications of this&#xD;
             therapy.&#xD;
&#xD;
          -  Patients with any concurrent active malignancy other than non-melanoma skin cancers or&#xD;
             carcinoma-in-situ of the cervix. Patients with previous malignancies but without&#xD;
             evidence of disease for &gt; 5 years will be allowed to enter the trial.&#xD;
&#xD;
          -  Patients with a history of non-compliance to medical regimens.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chuyan Chen, MD</last_name>
    <phone>+86-17701095670</phone>
    <email>chuyanchen921@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jingnan Li, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Delle Fave G, O'Toole D, Sundin A, Taal B, Ferolla P, Ramage JK, Ferone D, Ito T, Weber W, Zheng-Pei Z, De Herder WW, Pascher A, Ruszniewski P; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Gastroduodenal Neuroendocrine Neoplasms. Neuroendocrinology. 2016;103(2):119-24. doi: 10.1159/000443168. Epub 2016 Jan 19. No abstract available.</citation>
    <PMID>26784901</PMID>
  </reference>
  <reference>
    <citation>Merola E, Sbrozzi-Vanni A, Panzuto F, D'Ambra G, Di Giulio E, Pilozzi E, Capurso G, Lahner E, Bordi C, Annibale B, Delle Fave G. Type I gastric carcinoids: a prospective study on endoscopic management and recurrence rate. Neuroendocrinology. 2012;95(3):207-13. doi: 10.1159/000329043. Epub 2011 Jul 30.</citation>
    <PMID>21811050</PMID>
  </reference>
  <reference>
    <citation>Solcia E, Bordi C, Creutzfeldt W, Dayal Y, Dayan AD, Falkmer S, Grimelius L, Havu N. Histopathological classification of nonantral gastric endocrine growths in man. Digestion. 1988;41(4):185-200. doi: 10.1159/000199786.</citation>
    <PMID>3072229</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 20, 2019</last_update_submitted>
  <last_update_submitted_qc>January 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Jing-Nan Li</investigator_full_name>
    <investigator_title>Head of Gastroenterology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroendocrine Tumors</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Octreotide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03812939
org study id: ZS-1788
nct id: NCT03812939
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type
      I gastric neuroendocrine tumors.
observational model: Cohort
time perspective: Prospective
measure: Recurrence rate
time frame: 1 year
measure: Change in clinical symptoms
time frame: 6 months to 1 year
description: Measured by a questionnaire, including whether the patient presents with dyspepsia, abdominal pain, cramps, bloating, nausea, vomiting, lack of appetite, facial flushing.
measure: Concentration of serum Gastrin
time frame: 6 months to 1 year
description: Concentration of serum Gastrin after 12 hours of fasting
measure: Enterochromaffin-like cell (ECL) status
time frame: 6 months to 1 year
description: Normal Hyperplasia: ECL cell proliferation with a diameter <150 μm, distinguished in: normal pattern/simple hyperplasia, linear, micronodular and adenomatoid hyperplasia.
Dysplasia: ECL cell proliferation >150 but <500 μm. Type I gastric carcinoid: ECL proliferation >500 μm.
measure: Presence of side-effects of Octreotide
time frame: 6 months to 1 year
description: Measured by a questionnaire for patients and clinician's report. Including: hypersensitivity, endocrine disorders (abnormal thyroid functions), metabolism and nutrition disorders (abnormal blood glucose), headache, bradycardia or tachycardia, dyspnea, gastrointestinal disorders (diarrhea, abdominal pain, nausea, constipation, flatulence), hepatobiliary disorders, skin disorders, injection site reaction.
intervention type: Drug
intervention name: Octreotide
description: Patients will receive 6-12 monthly injections every 28 (+/- 3) days.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Chuyan Chen, MD
phone: +86-17701095670
email: chuyanchen921@126.com
facility: 
status: Recruiting
contact: 
country: China
citation: Delle Fave G, O'Toole D, Sundin A, Taal B, Ferolla P, Ramage JK, Ferone D, Ito T, Weber W, Zheng-Pei Z, De Herder WW, Pascher A, Ruszniewski P; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Gastroduodenal Neuroendocrine Neoplasms. Neuroendocrinology. 2016;103(2):119-24. doi: 10.1159/000443168. Epub 2016 Jan 19. No abstract available.
PMID: 26784901
citation: Merola E, Sbrozzi-Vanni A, Panzuto F, D'Ambra G, Di Giulio E, Pilozzi E, Capurso G, Lahner E, Bordi C, Annibale B, Delle Fave G. Type I gastric carcinoids: a prospective study on endoscopic management and recurrence rate. Neuroendocrinology. 2012;95(3):207-13. doi: 10.1159/000329043. Epub 2011 Jul 30.
PMID: 21811050
citation: Solcia E, Bordi C, Creutzfeldt W, Dayal Y, Dayan AD, Falkmer S, Grimelius L, Havu N. Histopathological classification of nonantral gastric endocrine growths in man. Digestion. 1988;41(4):185-200. doi: 10.1159/000199786.
PMID: 3072229
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Jing-Nan Li
investigator title: Head of Gastroenterology
mesh term: Neuroendocrine Tumors
mesh term: Recurrence
mesh term: Octreotide
sharing ipd: Undecided