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/NCT05991947</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-2023-427</org_study_id>
      <nct_id>NCT05991947</nct_id>
    </id_info>
    <brief_title>Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer</brief_title>
    <official_title>Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhejiang Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhejiang Cancer Hospital</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>
        This project aims to collect peripheral blood samples from newly diagnosed gastric cancer&#xD;
        patients and healthy individuals. Various techniques such as cfDNA sequencing, proteomics,&#xD;
        and fragmentomics will be employed to analyze differences in the expression of ctDNA&#xD;
        mutations, fragmentomics, and protein biomarkers between gastric cancer patients and healthy&#xD;
        individuals. A new comprehensive diagnostic model will be established and its diagnostic&#xD;
        value (sensitivity, specificity, accuracy, etc.) for gastric cancer will be validated.&#xD;
  &#xD;
        Specifically, the study will involve the following subjects and quantities: 700 participants&#xD;
        from Zhejiang Cancer Hospital (350 gastric cancer patients and 350 healthy individuals), 200&#xD;
        participants from Sichuan Cancer Hospital (100 gastric cancer patients and 100 healthy&#xD;
        individuals), and 200 participants from the Sixth Affiliated Hospital of Sun Yat-sen&#xD;
        University (100 gastric cancer patients and 100 healthy individuals). Peripheral blood&#xD;
        samples (a total of 15mL from each participant, collected in 3 tubes) will be collected from&#xD;
        all subjects. The collected blood samples will undergo multi-omics sequencing including cfDNA&#xD;
        methylation sequencing, proteomics, and genomics to establish a multi-omics-based early&#xD;
        diagnostic model.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>5 Years</target_duration>
    <primary_outcome>
      <measure>Differences in ctDNA gene and tumor-specific proteins expression</measure>
      <time_frame>First day in hospital</time_frame>
      <description>Collect 15ml of peripheral blood from subjects, extract ctDNA, and detect mutations in 18 genes (AKT1, APC, BRAF, CDKN2A, CTNNB1, EGFR, FBXW7, FGFR2, GNAS, HRAS, KRAS, NRAS, PIK3CA, PPP2R1A, PTEN, TP53, TOP2A, RNF43) and the expression levels of 9 tumor-specific proteins (CA-125, CA 19-9, CEA, HGF, IL-6, OPN, Prolactin, AFP, HE4) using the FireflyTM method based on amplicon library deep sequencing. Determine the performance indicators including sensitivity, specificity, and accuracy of the existing AccuScreen system and diagnostic model for early screening of gastric cancer. By conducting tests on 10 samples, explore the genomic fragments of gastric cancer, establish targets for ctDNA fragmentomics (fragment length, cleavage sites, end preferences, etc.), and analysis algorithms for gastric cancer fragmentomics, to further evaluate the feasibility of enhancing sensitivity and specificity for early gastric cancer screening through ctDNA fragmentomics detection.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1100</enrollment>
    <condition>Gastric Cancer</condition>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>gastric cancer patients</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>healthy individuals</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>No intervention measures are needed.</description>
      <arm_group_label>gastric cancer patients</arm_group_label>
      <arm_group_label>healthy individuals</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Number of Participants and Total Enrollment:&#xD;
  &#xD;
          Zhejiang Cancer Hospital: 700/700 (350 cases of gastric cancer patients, 350 cases of&#xD;
          healthy individuals) Sichuan Cancer Hospital: 200/200 (100 cases of gastric cancer&#xD;
          patients, 100 cases of healthy individuals) The Sixth Affiliated Hospital of Sun Yat-sen&#xD;
          University: 200/200 (100 cases of gastric cancer patients, 100 cases of healthy&#xD;
          individuals)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 18 and 100 years.&#xD;
  &#xD;
            -  ECOG performance status of 0 or 1.&#xD;
  &#xD;
            -  Pathologically confirmed Stage I-III gastric cancer patients.&#xD;
  &#xD;
            -  Patients who have not undergone any anti-tumor treatment (including chemotherapy,&#xD;
               radiotherapy, targeted therapy, surgery, anesthesia, etc.) before blood collection.&#xD;
  &#xD;
            -  Subjects and their family members who can comprehend the research protocol and are&#xD;
               willing to participate in the study, providing written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of other hereditary diseases or other tumors.&#xD;
  &#xD;
            -  Severe inflammatory reactions caused by acute illnesses within 14 days prior to blood&#xD;
               draw or use of steroids.&#xD;
  &#xD;
            -  Previous organ transplantation, stem cell transplantation, bone marrow&#xD;
               transplantation, or blood transfusion within the last month before enrollment.&#xD;
  &#xD;
            -  Pregnant women.&#xD;
  &#xD;
            -  Participation in other clinical trials requiring medication intake within the last 60&#xD;
               days (including anesthesia).&#xD;
  &#xD;
            -  Severe cardiovascular diseases, uncontrolled infections, or other uncontrollable&#xD;
               comorbidities.&#xD;
  &#xD;
            -  Subjects or family members unable to comprehend the conditions and objectives of the&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xiangdong Cheng, Professor</last_name>
      <phone>+86-13968032995</phone>
      <email>chengxd@zjcc.org.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Li Yuan, Professor</last_name>
      <phone>+86-15558103169</phone>
      <email>yuanli2768@zjcc.org.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiangdong Cheng, PhD.</last_name>
        <phone>+0086-0571-88128041</phone>
        <email>chengxd516@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhejiang Cancer Hospital</investigator_affiliation>
      <investigator_full_name>Xiangdong Cheng</investigator_full_name>
      <investigator_title>Secretary of the party committee</investigator_title>
    </responsible_party>
    <keyword>Gastric Cancer</keyword>
    <keyword>Proteomics</keyword>
    <keyword>Diagnostic model</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>This study does not involve clinical trials of drugs; it is solely designed to ensure the confidentiality of patient information. For participant information (such as names and ages), a coding system will be used instead of real names. After enrollment, each case will be assigned an enrollment number. Throughout the entire study, only the main researchers within the research team will have access to participants' real personal data (names, ages) in the electronic database. Distribution and sharing are prohibited. During the publication of articles, the main researchers within the research team will replace participant privacy information (names) with sample codes to achieve de-identification. Furthermore, the protection of participants' personal information will be maintained throughout the study, and any dissemination or leakage is strictly prohibited.</ipd_description>
    </patient_data>
    <!-- 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/NCT05991947
  org study id: IRB-2023-427
  nct id: NCT05991947
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This project aims to collect peripheral blood samples from newly diagnosed gastric cancer
        patients and healthy individuals. Various techniques such as cfDNA sequencing, proteomics,
        and fragmentomics will be employed to analyze differences in the expression of ctDNA
        mutations, fragmentomics, and protein biomarkers between gastric cancer patients and healthy
        individuals. A new comprehensive diagnostic model will be established and its diagnostic
        value (sensitivity, specificity, accuracy, etc.) for gastric cancer will be validated.
  
        Specifically, the study will involve the following subjects and quantities: 700 participants
        from Zhejiang Cancer Hospital (350 gastric cancer patients and 350 healthy individuals), 200
        participants from Sichuan Cancer Hospital (100 gastric cancer patients and 100 healthy
        individuals), and 200 participants from the Sixth Affiliated Hospital of Sun Yat-sen
        University (100 gastric cancer patients and 100 healthy individuals). Peripheral blood
        samples (a total of 15mL from each participant, collected in 3 tubes) will be collected from
        all subjects. The collected blood samples will undergo multi-omics sequencing including cfDNA
        methylation sequencing, proteomics, and genomics to establish a multi-omics-based early
        diagnostic model.
  observational model: Cohort
  time perspective: Prospective
  measure: Differences in ctDNA gene and tumor-specific proteins expression
  time frame: First day in hospital
  description: Collect 15ml of peripheral blood from subjects, extract ctDNA, and detect mutations in 18 genes (AKT1, APC, BRAF, CDKN2A, CTNNB1, EGFR, FBXW7, FGFR2, GNAS, HRAS, KRAS, NRAS, PIK3CA, PPP2R1A, PTEN, TP53, TOP2A, RNF43) and the expression levels of 9 tumor-specific proteins (CA-125, CA 19-9, CEA, HGF, IL-6, OPN, Prolactin, AFP, HE4) using the FireflyTM method based on amplicon library deep sequencing. Determine the performance indicators including sensitivity, specificity, and accuracy of the existing AccuScreen system and diagnostic model for early screening of gastric cancer. By conducting tests on 10 samples, explore the genomic fragments of gastric cancer, establish targets for ctDNA fragmentomics (fragment length, cleavage sites, end preferences, etc.), and analysis algorithms for gastric cancer fragmentomics, to further evaluate the feasibility of enhancing sensitivity and specificity for early gastric cancer screening through ctDNA fragmentomics detection.
  arm group label: gastric cancer patients
  arm group label: healthy individuals
  intervention type: Other
  intervention name: No intervention
  description: No intervention measures are needed.
  arm group label: gastric cancer patients
  arm group label: healthy individuals
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Xiangdong Cheng, Professor
  phone: +86-13968032995
  email: chengxd@zjcc.org.cn
  last name: Li Yuan, Professor
  phone: +86-15558103169
  email: yuanli2768@zjcc.org.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhejiang Cancer Hospital
  investigator full name: Xiangdong Cheng
  investigator title: Secretary of the party committee
  mesh term: Stomach Neoplasms
  sharing ipd: No
  ipd description: This study does not involve clinical trials of drugs; it is solely designed to ensure the confidentiality of patient information. For participant information (such as names and ages), a coding system will be used instead of real names. After enrollment, each case will be assigned an enrollment number. Throughout the entire study, only the main researchers within the research team will have access to participants' real personal data (names, ages) in the electronic database. Distribution and sharing are prohibited. During the publication of articles, the main researchers within the research team will replace participant privacy information (names) with sample codes to achieve de-identification. Furthermore, the protection of participants' personal information will be maintained throughout the study, and any dissemination or leakage is strictly prohibited.