<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/NCT04405557</url>
  </required_header>
  <id_info>
    <org_study_id>PREDICT</org_study_id>
    <nct_id>NCT04405557</nct_id>
  </id_info>
  <brief_title>The PREDICT Study: Prospective Early Detection In a Population at High-risk for Common Malignant Tumor</brief_title>
  <official_title>Study on the Application of ctDNA in a Population at High-risk for Common Malignant Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geneplus-Beijing Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Geneplus-Beijing Co. Ltd.</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>
      This is a observational, multicenter study, monitoring the circulating tumor DNA (ctDNA) in&#xD;
      people who is at risk of cancers，assessing the sensitivity and specificity of ctDNA detection&#xD;
      in early screening of pan-carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2000 patients with positive tumor protein markers or cancer screening were recruited. All&#xD;
      patients were tested for ctDNA at enrollment and followed up at 6 months and 1 year. The&#xD;
      study was completed at the time of cancer diagnosis or the longest follow-up time (1 year).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 12, 2019</start_date>
  <completion_date type="Anticipated">January 16, 2025</completion_date>
  <primary_completion_date type="Actual">January 16, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis of ctDNA for early detection in cancer high-risk population.</measure>
    <time_frame>1 year</time_frame>
    <description>To evaluate the sensitivity, specificity and positive predictive value of ctDNA for screening in high-risk population. Including the following six types of cancer: hepatocellular carcinoma, pancreatic cancer, ovarian cancer, breast cancer, colorectal cancer and gastric cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Window period from ctDNA positive to cancer diagnosis.</measure>
    <time_frame>1 year</time_frame>
    <description>To evaluate the time from ctDNA positive to cancer diagnosis for patients diagnosed with cancer during the trial period.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">757</enrollment>
  <condition>Early Detection of Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        People with positive tumor protein marker or cancer screening.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged at or over 45 years old.&#xD;
&#xD;
          2. Patients who with one or more of the following situations:&#xD;
&#xD;
               1. In AFP (&gt;20UG/L), CA125 (&gt;70U/ml), CEA (&gt;7ng/ml) and CA199 (&gt;60U/ml), more than&#xD;
                  one item was abnormal for two consecutive times within one month.&#xD;
&#xD;
               2. Patients with viral hepatitis (Hepatitis B / C surface antigen positive with&#xD;
                  liver function damage.&#xD;
&#xD;
               3. Patients with liver nodules detected by ultrasound and hemangioma excluded.&#xD;
&#xD;
               4. Patients with compensated cirrhosis.&#xD;
&#xD;
               5. CA125&gt;35U/ml and HE4 was abnormal (the reference value of HE4 in premenopausal&#xD;
                  and postmenopausal women was 68.96 pmol/L and 114.90 pmol/L respectively).&#xD;
&#xD;
               6. Patients with ovarian masses found by ultrasonography (premenopausal &gt; 5cm,&#xD;
                  postmenopausal &gt; 3.5cm).&#xD;
&#xD;
               7. Patients with pancreatic space-occupying found by ultrasonography.&#xD;
&#xD;
               8. Patients with BI-RADS grade 4 or above by ultrasound or mammography.&#xD;
&#xD;
               9. CA125&gt;35U/ml and BI-RADS above grade 3 by ultrasound or mammography.&#xD;
&#xD;
              10. CA153&gt;25U/ml and BI-RADS above grade 3 by ultrasound or mammography.&#xD;
&#xD;
              11. Family genetic history of breast cancer and ovarian cancer, and BI-RADS above&#xD;
                  grade 3 by ultrasound or mammography.&#xD;
&#xD;
              12. Patients with a positive fecal occult blood test and haemorrhoids excluded&#xD;
&#xD;
              13. Patients with a positive fecal occult blood test and positive CEA&#xD;
&#xD;
              14. More than 2 items were abnormal in PGI, PGR and G-17 (criteria: PGI≤70 UG/L,&#xD;
                  PGR≤7.0, G-17≤1 pmol/L or G-17≥15 pmol/L).&#xD;
&#xD;
          3. Ability to collect specimens from each time point and provide corresponding clinical&#xD;
             information.&#xD;
&#xD;
          4. Understand the research plan and voluntarily participate in the study, sign the&#xD;
             informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with previous or present cancer.&#xD;
&#xD;
          2. Patients with serious diseases, especially those with a survival period of less than 3&#xD;
             years.&#xD;
&#xD;
          3. Patients with factors that affect the diagnosis of the disease (such as MRI related&#xD;
             cardiac pacemakers, ferromagnetic implants, etc.).&#xD;
&#xD;
          4. Patients with a known history of allogeneic organ transplantation or allogeneic&#xD;
             hematopoietic stem cell transplantation.&#xD;
&#xD;
          5. Women who are pregnant or preparing for pregnancy.&#xD;
&#xD;
          6. Patients who voluntarily withdraw for any reason.&#xD;
&#xD;
          7. Patients who cannot complete the research plan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qiang Zeng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qiang Zeng, MD</last_name>
    <phone>13911736252</phone>
    <email>ZQ301@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qiang Zeng, MD</last_name>
      <phone>13911736252</phone>
      <email>ZQ301@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shenzhen People's Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weiqing Wu, MB</last_name>
      <phone>13802258083</phone>
      <email>wweiqing007@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yongli Li, MD</last_name>
      <phone>13633812936</phone>
      <email>shyliyongli@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shaohui Liu, MB</last_name>
      <phone>13337313360</phone>
      <email>shaohui_liu@msn.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qun Zhang, MD</last_name>
      <phone>13805182208</phone>
      <email>jszhangqun@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>China-Japan Union Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130033</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongjun Li, MD</last_name>
      <phone>13844075818</phone>
      <email>lihongjun@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Jinzhou Medical University</name>
      <address>
        <city>Jinzhou</city>
        <state>Liaoning</state>
        <zip>121001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhitu Zhu, MD</last_name>
      <phone>13897872139</phone>
      <email>ZHUZHITU@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sichuan Provincial People's Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610072</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuping Liu, MM</last_name>
      <phone>18981838972</phone>
      <email>liuyuping555@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 9, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 25, 2023</last_update_submitted>
  <last_update_submitted_qc>May 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pan-cancer</keyword>
  <keyword>cancer screening</keyword>
  <keyword>ctDNA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04405557
org study id: PREDICT
nct id: NCT04405557
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a observational, multicenter study, monitoring the circulating tumor DNA (ctDNA) in
      people who is at risk of cancers，assessing the sensitivity and specificity of ctDNA detection
      in early screening of pan-carcinoma.
2000 patients with positive tumor protein markers or cancer screening were recruited. All
      patients were tested for ctDNA at enrollment and followed up at 6 months and 1 year. The
      study was completed at the time of cancer diagnosis or the longest follow-up time (1 year).
observational model: Case-Only
time perspective: Prospective
measure: Analysis of ctDNA for early detection in cancer high-risk population.
time frame: 1 year
description: To evaluate the sensitivity, specificity and positive predictive value of ctDNA for screening in high-risk population. Including the following six types of cancer: hepatocellular carcinoma, pancreatic cancer, ovarian cancer, breast cancer, colorectal cancer and gastric cancer.
measure: Window period from ctDNA positive to cancer diagnosis.
time frame: 1 year
description: To evaluate the time from ctDNA positive to cancer diagnosis for patients diagnosed with cancer during the trial period.
plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Qiang Zeng, MD
role: Principal Investigator
affiliation: Chinese PLA General Hospital
last name: Qiang Zeng, MD
phone: 13911736252
email: ZQ301@126.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms