<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/NCT04444947</url>
  </required_header>
  <id_info>
    <org_study_id>2019-SR-340</org_study_id>
    <nct_id>NCT04444947</nct_id>
  </id_info>
  <brief_title>Influencing Factors in Patients With Colorectal and Gastric Polyps a Retrospective Study</brief_title>
  <official_title>Influencing Factors in Patients With Colorectal and Gastric a Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The identification of risk factors of colorectal/gastric polyp is more helpful for preventing&#xD;
      colorectal cancer. And modifiable factors (such as high-fat diet, abnormal blood lipid,&#xD;
      smoking, lack of exercise, obesity), and unmodifiable factors (including age, gender, race,&#xD;
      familial adenomas, genetic)) can affect the risk of polyps. Thus early studying risk factors&#xD;
      are the key to improving prognosis. what's more, early detection and timely treatment have&#xD;
      important clinical significance for preventing and reducing the occurrence of&#xD;
      gastrointestinal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer (CRC) is the third most common cancer in the world. what's more, CRC is&#xD;
      therefore an important public health concern in China due to its rising incidence and&#xD;
      prevalence, in addition to the burden of disease. There is robust evidence indicating that&#xD;
      early detection by screening and removal of cancer precursor lesions offers an effective&#xD;
      method of reducing colorectal cancer morbidity and mortality. Studies have shown that&#xD;
      colorectal polyps are considered to be related to colorectal cancer, especially adenoma .The&#xD;
      primary aim of this study was to identify high risk features of multiple polyps based on&#xD;
      size, location and histological type. Patient age and gender were also characterized on the&#xD;
      basis of a contingency analysis of a large series of Chinese patients with colorectal polyps.&#xD;
      These data provide important information on risk factors associated with multiple polyps,&#xD;
      which will serve as evidence for an individualized approach to colonoscopy screening&#xD;
      guidelines in China.&#xD;
&#xD;
      Similarly, recent years, with the widespread use of gastroscopy, people's health awareness&#xD;
      and lifestyle changes, more and more people have performed gastroscopy, so a large number of&#xD;
      patients with gastric polyps can be found in the clinic. Gastric polyps are raised lesions&#xD;
      that originate in the mucosal layer or submucosa and protrude into the stomach cavity.&#xD;
      According to their pathological characteristics, they can be divided into two categories:&#xD;
      mucosal layer and non-mucosal layer.Gastric polyps originating from mucosal layers,&#xD;
      represented by natural, fundus glandular and adenomatous polyps, are the most common in&#xD;
      clinical practice, while non-mucosal polyps including gastric stromal tumors and inflammatory&#xD;
      fibrous polyps are more common in clinical practice. Although the incidence of gastric polyps&#xD;
      is far less than that of intestinal polyps, some pathological types, especially adenomatous&#xD;
      polyps, have obvious malignant potential and are recognized as precancerous lesions .&#xD;
&#xD;
      Therefore, we retrospectively analyzed the records of patients with gastrointestinal polyps&#xD;
      in our hospital in the past years, and provided epidemiological data to study the factors in&#xD;
      polyps.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Influencing factors in patients with colorectal polyps: a retrospective study</measure>
    <time_frame>JUNE 30,2020</time_frame>
    <description>risk factors</description>
  </primary_outcome>
  <enrollment type="Actual">64889</enrollment>
  <condition>Polyp, Colonic</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 43,104, patients (n=21939) with polyps and patients without polyps (n=21165) is&#xD;
        included in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who underwent colonoscopies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) Patients with Crohn's disease, inflammatory bowel disease, and colorectal cancer;&#xD;
             (2) Patients with ulcerative bowel disease, and intestinal tuberculosis; (3) Patients&#xD;
             with history of familial polyposis; (4) All patients without complete endoscopic&#xD;
             reports and complete demographics records.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yue WANG, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>the Human Ethics Committee of Jiangsu Provincial People's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jiangsu Provincial People's Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Han X, Qian W, Liu Y, Zheng T, Su XJ, Zhang PP, Chen Y, Hu LH, Li ZS. Effects of age, sex and pathological type on the risk of multiple polyps: A Chinese teaching hospital study. J Dig Dis. 2020 Sep;21(9):505-511. doi: 10.1111/1751-2980.12863.</citation>
    <PMID>32279448</PMID>
  </results_reference>
  <results_reference>
    <citation>Song M, Emilsson L, Bozorg SR, Nguyen LH, Joshi AD, Staller K, Nayor J, Chan AT, Ludvigsson JF. Risk of colorectal cancer incidence and mortality after polypectomy: a Swedish record-linkage study. Lancet Gastroenterol Hepatol. 2020 Jun;5(6):537-547. doi: 10.1016/S2468-1253(20)30009-1. Epub 2020 Mar 17.</citation>
    <PMID>32192628</PMID>
  </results_reference>
  <results_reference>
    <citation>Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011 Jan 19;103(2):117-28. doi: 10.1093/jnci/djq495. Epub 2011 Jan 12. Erratum In: J Natl Cancer Inst. 2011 Apr 20;103(8):699.</citation>
    <PMID>21228314</PMID>
  </results_reference>
  <results_reference>
    <citation>Oines M, Helsingen LM, Bretthauer M, Emilsson L. Epidemiology and risk factors of colorectal polyps. Best Pract Res Clin Gastroenterol. 2017 Aug;31(4):419-424. doi: 10.1016/j.bpg.2017.06.004. Epub 2017 Jun 28.</citation>
    <PMID>28842051</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 21, 2020</last_update_submitted>
  <last_update_submitted_qc>June 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</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>Polyps</mesh_term>
    <mesh_term>Colonic Polyps</mesh_term>
  </condition_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/NCT04444947
org study id: 2019-SR-340
nct id: NCT04444947
lead sponsor: 
has dmc: Yes
The identification of risk factors of colorectal/gastric polyp is more helpful for preventing
      colorectal cancer. And modifiable factors (such as high-fat diet, abnormal blood lipid,
      smoking, lack of exercise, obesity), and unmodifiable factors (including age, gender, race,
      familial adenomas, genetic)) can affect the risk of polyps. Thus early studying risk factors
      are the key to improving prognosis. what's more, early detection and timely treatment have
      important clinical significance for preventing and reducing the occurrence of
      gastrointestinal cancer.
Colorectal cancer (CRC) is the third most common cancer in the world. what's more, CRC is
      therefore an important public health concern in China due to its rising incidence and
      prevalence, in addition to the burden of disease. There is robust evidence indicating that
      early detection by screening and removal of cancer precursor lesions offers an effective
      method of reducing colorectal cancer morbidity and mortality. Studies have shown that
      colorectal polyps are considered to be related to colorectal cancer, especially adenoma .The
      primary aim of this study was to identify high risk features of multiple polyps based on
      size, location and histological type. Patient age and gender were also characterized on the
      basis of a contingency analysis of a large series of Chinese patients with colorectal polyps.
      These data provide important information on risk factors associated with multiple polyps,
      which will serve as evidence for an individualized approach to colonoscopy screening
      guidelines in China.

      Similarly, recent years, with the widespread use of gastroscopy, people's health awareness
      and lifestyle changes, more and more people have performed gastroscopy, so a large number of
      patients with gastric polyps can be found in the clinic. Gastric polyps are raised lesions
      that originate in the mucosal layer or submucosa and protrude into the stomach cavity.
      According to their pathological characteristics, they can be divided into two categories:
      mucosal layer and non-mucosal layer.Gastric polyps originating from mucosal layers,
      represented by natural, fundus glandular and adenomatous polyps, are the most common in
      clinical practice, while non-mucosal polyps including gastric stromal tumors and inflammatory
      fibrous polyps are more common in clinical practice. Although the incidence of gastric polyps
      is far less than that of intestinal polyps, some pathological types, especially adenomatous
      polyps, have obvious malignant potential and are recognized as precancerous lesions .

      Therefore, we retrospectively analyzed the records of patients with gastrointestinal polyps
      in our hospital in the past years, and provided epidemiological data to study the factors in
      polyps.
observational model: Case-Control
time perspective: Other
measure: Influencing factors in patients with colorectal polyps: a retrospective study
time frame: JUNE 30,2020
description: risk factors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: yue WANG, master
role: Principal Investigator
affiliation: the Human Ethics Committee of Jiangsu Provincial People's Hospital
facility: 
country: China
citation: Han X, Qian W, Liu Y, Zheng T, Su XJ, Zhang PP, Chen Y, Hu LH, Li ZS. Effects of age, sex and pathological type on the risk of multiple polyps: A Chinese teaching hospital study. J Dig Dis. 2020 Sep;21(9):505-511. doi: 10.1111/1751-2980.12863.
PMID: 32279448
citation: Song M, Emilsson L, Bozorg SR, Nguyen LH, Joshi AD, Staller K, Nayor J, Chan AT, Ludvigsson JF. Risk of colorectal cancer incidence and mortality after polypectomy: a Swedish record-linkage study. Lancet Gastroenterol Hepatol. 2020 Jun;5(6):537-547. doi: 10.1016/S2468-1253(20)30009-1. Epub 2020 Mar 17.
PMID: 32192628
citation: Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011 Jan 19;103(2):117-28. doi: 10.1093/jnci/djq495. Epub 2011 Jan 12. Erratum In: J Natl Cancer Inst. 2011 Apr 20;103(8):699.
PMID: 21228314
citation: Oines M, Helsingen LM, Bretthauer M, Emilsson L. Epidemiology and risk factors of colorectal polyps. Best Pract Res Clin Gastroenterol. 2017 Aug;31(4):419-424. doi: 10.1016/j.bpg.2017.06.004. Epub 2017 Jun 28.
PMID: 28842051
responsible party type: Sponsor
mesh term: Polyps
mesh term: Colonic Polyps
sharing ipd: Undecided