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/NCT06000553</url>
    </required_header>
    <id_info>
      <org_study_id>PCS-IPMN-IPC 2023-005</org_study_id>
      <nct_id>NCT06000553</nct_id>
    </id_info>
    <brief_title>Early Detection of Pancreatic Cancer in Patients With Papillary and Mucinous Intracanal Tumours of the Pancreas Papillary and Mucinous Tumours of the Pancreas</brief_title>
    <official_title>Early Detection of Pancreatic Cancer in Patients With Papillary and Mucinous Intracanal Tumours of the Pancreas Papillary and Mucinous Tumours of the Pancreas PCS-IPMN-IPC 2023-005</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut Paoli-Calmettes</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institut Paoli-Calmettes</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 trial is a prospective, exploratory and descriptive study. The primary objective is to&#xD;
        identify early diagnostic biomarkers in patients with TIPMP based on the analysis of Treg&#xD;
        lymphocyte subpopulations and epigenetic signatures, and the secondary objective is to&#xD;
        characterize the biological processes underlying the transformation of a pre-neoplastic&#xD;
        lesion into established ADPC.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To meet the objectives of the study, patients will have blood samples taken at the time of&#xD;
        their TIPMP monitoring, i.e. at inclusion, 6 months, 1 year and 2 years. If echo-endoscopy is&#xD;
        performed during MRI monitoring of their disease, and a sample is taken as part of the&#xD;
        treatment, a tumor sample and an intra-cystic fluid sample will be collected as part of the&#xD;
        protocol.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 30, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>the patient takes specific blood samples for the study</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the aim is to search for immune and metabolic abnormalities in patients with at-risk TIPMP in the blood or by echo-endoscopic sampling, then compare and combine them with the criteria used in clinical practice.</measure>
      <time_frame>for two years</time_frame>
      <description>Biomarkers will be studied to determine whether those selected have been effective in identifying patients with pancreatic adenocarcinoma.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">360</enrollment>
    <condition>PAPILLARY AND MUCINOUS INTRACANAL TUMORS OF THE PANCREAS</condition>
    <arm_group>
      <arm_group_label>collection of blood and tumor samples</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>blood sampling at inclusion, 6 months, 1 year and 2 years. Tumor and intracystic fluid samples are taken only if a biopsy is planned following MRI results.</intervention_name>
      <description>If the patient agrees to take part in the study, he or she will have a blood sample taken from 8 x 4 ml EDTA tubes at the time of inclusion in the trial.Then, at 6 months (+/- 1 month), 1 year and 2 years, the patient will have the same blood sample as at inclusion.If a biopsy is performed as part of routine care, a tumor sample will be taken and sent to the IPC pathology department for FFPE block. If a biopsy is performed and the patient consents, a cystic fluid sample will be taken.</description>
      <arm_group_label>collection of blood and tumor samples</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age over 18&#xD;
  &#xD;
            2. Patient with intermediate-risk or high-risk TIPMP according to the European Study&#xD;
               Group on Cystic Tumours of the Pancreas (3)&#xD;
  &#xD;
            3. Signed consent to participate&#xD;
  &#xD;
            4. Affiliation with a social security scheme, or beneficiary of such a scheme.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant or breast-feeding woman&#xD;
  &#xD;
            2. Person in an emergency situation or unable to give consent.&#xD;
  &#xD;
            3. Adult subject to a legal protection measure (adult under guardianship, curatorship or&#xD;
               safeguard of justice),&#xD;
  &#xD;
            4. Unable to undergo medical follow-up for geographical, social or psychological reasons.&#xD;
  &#xD;
            5. contraindication to MRI.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dominique GENRE, MD</last_name>
      <phone>049122</phone>
      <email>drci.up@ipc.unicancer.fr</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>Pancreatic Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT06000553
  org study id: PCS-IPMN-IPC 2023-005
  nct id: NCT06000553
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This trial is a prospective, exploratory and descriptive study. The primary objective is to
        identify early diagnostic biomarkers in patients with TIPMP based on the analysis of Treg
        lymphocyte subpopulations and epigenetic signatures, and the secondary objective is to
        characterize the biological processes underlying the transformation of a pre-neoplastic
        lesion into established ADPC.
  To meet the objectives of the study, patients will have blood samples taken at the time of
        their TIPMP monitoring, i.e. at inclusion, 6 months, 1 year and 2 years. If echo-endoscopy is
        performed during MRI monitoring of their disease, and a sample is taken as part of the
        treatment, a tumor sample and an intra-cystic fluid sample will be collected as part of the
        protocol.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: the patient takes specific blood samples for the study
  primary purpose: Other
  masking: None (Open Label)
  measure: the aim is to search for immune and metabolic abnormalities in patients with at-risk TIPMP in the blood or by echo-endoscopic sampling, then compare and combine them with the criteria used in clinical practice.
  time frame: for two years
  description: Biomarkers will be studied to determine whether those selected have been effective in identifying patients with pancreatic adenocarcinoma.
  arm group label: collection of blood and tumor samples
  arm group type: Other
  intervention type: Other
  intervention name: blood sampling at inclusion, 6 months, 1 year and 2 years. Tumor and intracystic fluid samples are taken only if a biopsy is planned following MRI results.
  description: If the patient agrees to take part in the study, he or she will have a blood sample taken from 8 x 4 ml EDTA tubes at the time of inclusion in the trial.Then, at 6 months (+/- 1 month), 1 year and 2 years, the patient will have the same blood sample as at inclusion.If a biopsy is performed as part of routine care, a tumor sample will be taken and sent to the IPC pathology department for FFPE block. If a biopsy is performed and the patient consents, a cystic fluid sample will be taken.
  arm group label: collection of blood and tumor samples
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Dominique GENRE, MD
  phone: 049122
  email: drci.up@ipc.unicancer.fr
  responsible party type: Sponsor
  mesh term: Pancreatic Neoplasms
  sharing ipd: Undecided