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/NCT05985577</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-2023-584</org_study_id>
      <nct_id>NCT05985577</nct_id>
    </id_info>
    <brief_title>Mechanism of Gastric Signet Ring Cell Carcinoma Based on Microproteomics</brief_title>
    <official_title>Mechanism of Gastric Signet Ring Cell Carcinoma Based on Microproteomics</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>
        Gastric signet ring cell carcinoma (GSRCC) possesses unique epidemiology and pathogenesis in&#xD;
        the field of cancer, but its incidence is low. Unfortunately, there is currently a lack of&#xD;
        systematic research focusing on the prognostic proteomic features of GSRCC. Given this&#xD;
        knowledge gap, this study aims to comprehensively characterize the proteomic landscape of&#xD;
        GSRCC using a reliable and reproducible DIA-PCT method. This study objectives include&#xD;
        characterizing the heterogeneity of GSRCC, performing molecular typing, identifying potential&#xD;
        biomarkers and therapeutic targets, and providing a resource for stratified analysis of&#xD;
        GSRCC. To achieve these goals, the investigators selected a cohort of 112 GSRCC patients from&#xD;
        a pool of over 10,000 gastric cancer patients and conducted a proteomic analysis using the&#xD;
        DIA-PCT method. This meticulous approach revealed four novel proteomic subtypes of GSRCC,&#xD;
        each exhibiting unique molecular characteristics. Additionally, the investigators discovered&#xD;
        that PRDX2 and DDX27 can serve as predictive biomarkers for GSRCC, which were further&#xD;
        validated in an independent cohort of 75 GSRCC patients. Furthermore, the investigators paid&#xD;
        particular attention to the MLT-GSRCC subgroup and identified three distinct proteomic&#xD;
        clusters among MLT-GSRCC patients. Subtype 2 within this subgroup demonstrated the poorest&#xD;
        prognosis. Through a rigorous screening process, the investigators determined potential&#xD;
        targets for the treatment of GSRCC. In conclusion, these findings contribute to the&#xD;
        investigators understanding of the heterogeneity of GSRCC and provide valuable resources for&#xD;
        future clinical stratification and targeted treatment strategies.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 2, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>10 Years</target_duration>
    <primary_outcome>
      <measure>The proteome of tissue</measure>
      <time_frame>Lc-MS/MS was used to detect the types of proteins in the samples and the relative amounts in the samples compared with Normal adjacent tissue, an average of one month</time_frame>
      <description>The samples diagnosed as GSRCC by pathology were selected as the samples with signet ring cell content &gt; 70% as judged by 2 pathologists of associate chief physician or above and without previous radiotherapy and chemotherapy. Tumor tissues and paired nat were collected from the same patient at the time of tumor resection and stored in formalin-fixed paraffin embedding (FFPE). Liquid chromatography-mass spectrometry (LC-MS) was used to detect the proteomics in the samples. The proteins in the samples were extracted, and the proteomics in the samples was detected by LC-MS. Qualitative and quantitative analysis was performed to detect the types and content of proteins in the samples.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Gastric Cancer</condition>
    <condition>Signet Ring Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Cancer tissues</arm_group_label>
      <description>Cancer tissues</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Normal adjacent tissues</arm_group_label>
      <description>Normal adjacent tissues</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Without any intervention</intervention_name>
      <description>There were no special interventions for the two groups.</description>
      <arm_group_label>Cancer tissues</arm_group_label>
      <arm_group_label>Normal adjacent tissues</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Biological samples are used for proteomic analysis.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          These cases had a signet ring cell content greater than 70% and had not undergone prior&#xD;
          chemotherapy or radiotherapy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  confirmed GSRCC by pathology, where GSRCC is defined as having a percentage of signet&#xD;
               ring cell ≥ 50%&#xD;
  &#xD;
            -  patients with complete medical information&#xD;
  &#xD;
            -  patients with survival follow-up information&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with other malignant tumors&#xD;
  &#xD;
            -  presence of other pathological components (e.g., neuroendocrine carcinoma and squamous&#xD;
               cell carcinoma, etc)&#xD;
  &#xD;
            -  incomplete or lost case information&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <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>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Puccini A, Poorman K, Catalano F, Seeber A, Goldberg RM, Salem ME, Shields AF, Berger MD, Battaglin F, Tokunaga R, Naseem M, Zhang W, Philip PA, Marshall JL, Korn WM, Lenz HJ. Molecular profiling of signet-ring-cell carcinoma (SRCC) from the stomach and colon reveals potential new therapeutic targets. Oncogene. 2022 Jun;41(26):3455-3460. doi: 10.1038/s41388-022-02350-6. Epub 2022 May 26.</citation>
      <PMID>35618879</PMID>
    </results_reference>
    <results_reference>
      <citation>Fan Y, Bai B, Liang Y, Ren Y, Liu Y, Zhou F, Lou X, Zi J, Hou G, Chen F, Zhao Q, Liu S. Proteomic Profiling of Gastric Signet Ring Cell Carcinoma Tissues Reveals Characteristic Changes of the Complement Cascade Pathway. Mol Cell Proteomics. 2021;20:100068. doi: 10.1016/j.mcpro.2021.100068. Epub 2021 Mar 3.</citation>
      <PMID>33676000</PMID>
    </results_reference>
    <results_reference>
      <citation>Ge S, Xia X, Ding C, Zhen B, Zhou Q, Feng J, Yuan J, Chen R, Li Y, Ge Z, Ji J, Zhang L, Wang J, Li Z, Lai Y, Hu Y, Li Y, Li Y, Gao J, Chen L, Xu J, Zhang C, Jung SY, Choi JM, Jain A, Liu M, Song L, Liu W, Guo G, Gong T, Huang Y, Qiu Y, Huang W, Shi T, Zhu W, Wang Y, He F, Shen L, Qin J. A proteomic landscape of diffuse-type gastric cancer. Nat Commun. 2018 Mar 8;9(1):1012. doi: 10.1038/s41467-018-03121-2. Erratum In: Nat Commun. 2018 May 8;9(1):1850.</citation>
      <PMID>29520031</PMID>
    </results_reference>
    <results_reference>
      <citation>Asleh K, Negri GL, Spencer Miko SE, Colborne S, Hughes CS, Wang XQ, Gao D, Gilks CB, Chia SKL, Nielsen TO, Morin GB. Proteomic analysis of archival breast cancer clinical specimens identifies biological subtypes with distinct survival outcomes. Nat Commun. 2022 Feb 16;13(1):896. doi: 10.1038/s41467-022-28524-0.</citation>
      <PMID>35173148</PMID>
    </results_reference>
    <results_reference>
      <citation>Chen J, Liu K, Luo Y, Kang M, Wang J, Chen G, Qi J, Wu W, Wang B, Han Y, Shi L, Wang K, Han X, Ma X, Liu W, Ding Y, Wang L, Liang H, Wang L, Chen J. Single-Cell Profiling of Tumor Immune Microenvironment Reveals Immune Irresponsiveness in Gastric Signet-Ring Cell Carcinoma. Gastroenterology. 2023 Jul;165(1):88-103. doi: 10.1053/j.gastro.2023.03.008. Epub 2023 Mar 14.</citation>
      <PMID>36921674</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 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 signet ring cell carcinoma</keyword>
    <keyword>Molecular Subtypes</keyword>
    <keyword>Proteomics</keyword>
    <keyword>Prognostic markers</keyword>
    <keyword>Drug target</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Signet Ring Cell</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>This study does not involve drug clinical trials but focuses on ensuring the confidentiality of patient information. To protect patient privacy, a coding system was used instead of real names when entering patient information such as names and ages. Each patient was assigned a study identification number upon enrollment. Throughout the entire study, only the main researchers in the research team have the authority to access the true personal data of patients obtained from the electronic database (such as names and ages), and it is strictly prohibited to circulate or share this information. During the publication of the research article, the main researchers in the research team will use sample coding to replace patient privacy information (such as names) to achieve de-identification. Additionally, the protection of personal information for study participants must be maintained throughout the entire research process, and it is strictly forbidden to circulate or leak such information.</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/NCT05985577
  org study id: IRB-2023-584
  nct id: NCT05985577
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Gastric signet ring cell carcinoma (GSRCC) possesses unique epidemiology and pathogenesis in
        the field of cancer, but its incidence is low. Unfortunately, there is currently a lack of
        systematic research focusing on the prognostic proteomic features of GSRCC. Given this
        knowledge gap, this study aims to comprehensively characterize the proteomic landscape of
        GSRCC using a reliable and reproducible DIA-PCT method. This study objectives include
        characterizing the heterogeneity of GSRCC, performing molecular typing, identifying potential
        biomarkers and therapeutic targets, and providing a resource for stratified analysis of
        GSRCC. To achieve these goals, the investigators selected a cohort of 112 GSRCC patients from
        a pool of over 10,000 gastric cancer patients and conducted a proteomic analysis using the
        DIA-PCT method. This meticulous approach revealed four novel proteomic subtypes of GSRCC,
        each exhibiting unique molecular characteristics. Additionally, the investigators discovered
        that PRDX2 and DDX27 can serve as predictive biomarkers for GSRCC, which were further
        validated in an independent cohort of 75 GSRCC patients. Furthermore, the investigators paid
        particular attention to the MLT-GSRCC subgroup and identified three distinct proteomic
        clusters among MLT-GSRCC patients. Subtype 2 within this subgroup demonstrated the poorest
        prognosis. Through a rigorous screening process, the investigators determined potential
        targets for the treatment of GSRCC. In conclusion, these findings contribute to the
        investigators understanding of the heterogeneity of GSRCC and provide valuable resources for
        future clinical stratification and targeted treatment strategies.
  observational model: Case-Only
  time perspective: Other
  measure: The proteome of tissue
  time frame: Lc-MS/MS was used to detect the types of proteins in the samples and the relative amounts in the samples compared with Normal adjacent tissue, an average of one month
  description: The samples diagnosed as GSRCC by pathology were selected as the samples with signet ring cell content > 70% as judged by 2 pathologists of associate chief physician or above and without previous radiotherapy and chemotherapy. Tumor tissues and paired nat were collected from the same patient at the time of tumor resection and stored in formalin-fixed paraffin embedding (FFPE). Liquid chromatography-mass spectrometry (LC-MS) was used to detect the proteomics in the samples. The proteins in the samples were extracted, and the proteomics in the samples was detected by LC-MS. Qualitative and quantitative analysis was performed to detect the types and content of proteins in the samples.
  arm group label: Cancer tissues
  description: Cancer tissues
  arm group label: Normal adjacent tissues
  description: Normal adjacent tissues
  intervention type: Other
  intervention name: Without any intervention
  description: There were no special interventions for the two groups.
  arm group label: Cancer tissues
  arm group label: Normal adjacent tissues
  Biological samples are used for proteomic analysis.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  citation: Puccini A, Poorman K, Catalano F, Seeber A, Goldberg RM, Salem ME, Shields AF, Berger MD, Battaglin F, Tokunaga R, Naseem M, Zhang W, Philip PA, Marshall JL, Korn WM, Lenz HJ. Molecular profiling of signet-ring-cell carcinoma (SRCC) from the stomach and colon reveals potential new therapeutic targets. Oncogene. 2022 Jun;41(26):3455-3460. doi: 10.1038/s41388-022-02350-6. Epub 2022 May 26.
  PMID: 35618879
  citation: Fan Y, Bai B, Liang Y, Ren Y, Liu Y, Zhou F, Lou X, Zi J, Hou G, Chen F, Zhao Q, Liu S. Proteomic Profiling of Gastric Signet Ring Cell Carcinoma Tissues Reveals Characteristic Changes of the Complement Cascade Pathway. Mol Cell Proteomics. 2021;20:100068. doi: 10.1016/j.mcpro.2021.100068. Epub 2021 Mar 3.
  PMID: 33676000
  citation: Ge S, Xia X, Ding C, Zhen B, Zhou Q, Feng J, Yuan J, Chen R, Li Y, Ge Z, Ji J, Zhang L, Wang J, Li Z, Lai Y, Hu Y, Li Y, Li Y, Gao J, Chen L, Xu J, Zhang C, Jung SY, Choi JM, Jain A, Liu M, Song L, Liu W, Guo G, Gong T, Huang Y, Qiu Y, Huang W, Shi T, Zhu W, Wang Y, He F, Shen L, Qin J. A proteomic landscape of diffuse-type gastric cancer. Nat Commun. 2018 Mar 8;9(1):1012. doi: 10.1038/s41467-018-03121-2. Erratum In: Nat Commun. 2018 May 8;9(1):1850.
  PMID: 29520031
  citation: Asleh K, Negri GL, Spencer Miko SE, Colborne S, Hughes CS, Wang XQ, Gao D, Gilks CB, Chia SKL, Nielsen TO, Morin GB. Proteomic analysis of archival breast cancer clinical specimens identifies biological subtypes with distinct survival outcomes. Nat Commun. 2022 Feb 16;13(1):896. doi: 10.1038/s41467-022-28524-0.
  PMID: 35173148
  citation: Chen J, Liu K, Luo Y, Kang M, Wang J, Chen G, Qi J, Wu W, Wang B, Han Y, Shi L, Wang K, Han X, Ma X, Liu W, Ding Y, Wang L, Liang H, Wang L, Chen J. Single-Cell Profiling of Tumor Immune Microenvironment Reveals Immune Irresponsiveness in Gastric Signet-Ring Cell Carcinoma. Gastroenterology. 2023 Jul;165(1):88-103. doi: 10.1053/j.gastro.2023.03.008. Epub 2023 Mar 14.
  PMID: 36921674
  responsible party type: Principal Investigator
  investigator affiliation: Zhejiang Cancer Hospital
  investigator full name: Xiangdong Cheng
  investigator title: Secretary of the party committee
  mesh term: Carcinoma
  mesh term: Carcinoma, Signet Ring Cell
  sharing ipd: No
  ipd description: This study does not involve drug clinical trials but focuses on ensuring the confidentiality of patient information. To protect patient privacy, a coding system was used instead of real names when entering patient information such as names and ages. Each patient was assigned a study identification number upon enrollment. Throughout the entire study, only the main researchers in the research team have the authority to access the true personal data of patients obtained from the electronic database (such as names and ages), and it is strictly prohibited to circulate or share this information. During the publication of the research article, the main researchers in the research team will use sample coding to replace patient privacy information (such as names) to achieve de-identification. Additionally, the protection of personal information for study participants must be maintained throughout the entire research process, and it is strictly forbidden to circulate or leak such information.