<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/NCT04473794</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00249790</org_study_id>
    <secondary_id>5P50CA062924</secondary_id>
    <nct_id>NCT04473794</nct_id>
  </id_info>
  <brief_title>Diagnostic Strategies, Risk Assessment and Progression of Pancreatic Cysts</brief_title>
  <official_title>Diagnostic Strategies, Risk Assessment and Progression of Pancreatic Cysts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</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>
      The aims of this study are to determine the natural history of pancreatic cysts and to&#xD;
      propose and prospectively validate a diagnostic approach and model for prediction of mucinous&#xD;
      versus non-mucinous, and malignant versus non-malignant, pancreatic cysts using a combination&#xD;
      of clinical, radiologic, and biomarker characteristics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreatic cysts are increasingly recognized as incidental lesions due to the widespread use&#xD;
      of cross-sectional imaging techniques such as CT and MRI. Twenty percent of all pancreatic&#xD;
      cysts are non-inflammatory cystic neoplasms, many of which are mucinous, and therefore have a&#xD;
      significant potential for malignant transformation. The primary challenge facing clinicians&#xD;
      is the inability of current standard diagnostic tests, including imaging and standard&#xD;
      laboratory data, to accurately and reliably discriminate neoplastic from non-neoplastic, and&#xD;
      benign from malignant cysts, particularly in patients without symptoms. Therefore, some&#xD;
      patients with benign cysts undergo unnecessary costly surveillance and possible avoidable&#xD;
      surgical resections, which is associated with high cost, significant morbidity and mortality,&#xD;
      while some may not be as aggressively followed. The International Association of&#xD;
      Pancreatology (IAP) has published guidelines on the management of the two main types of&#xD;
      mucinous cystic lesions: intraductal papillary mucinous neoplasms (IPMNs) and mucinous cystic&#xD;
      neoplasms (MCNs). (1) Although these guidelines emphasize the frequency of surveillance and&#xD;
      outline the indications for resection, these guidelines have not yet been validated, and&#xD;
      these guidelines presume the diagnosis of a mucinous neoplastic cyst has been confirmed prior&#xD;
      to surgery. It is unlikely that guidelines that only use clinical and imaging will be able to&#xD;
      accurately differentiate benign cysts from those that are pre-malignant or currently harbor&#xD;
      malignancy. Hence, there is a critical need for a diagnostic model that more accurately&#xD;
      diagnoses neoplastic mucinous and malignant pancreatic cysts as this will improve the&#xD;
      management of many patients with pancreatic cysts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 20, 2022</start_date>
  <completion_date type="Anticipated">August 1, 2036</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2026</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>Clinical utility of Compcyst in pancreatic cysts as assessed by patient chart review</measure>
    <time_frame>15 years</time_frame>
    <description>Compcyst is part of the new standard of care diagnosis of precancerous and benign cystic lesions. Patient charts will be reviewed for clinical, radiological, surgical and pathologic information (all combined into a composite) that will be used to determine if Compcyst as part of the new standard of care is better than the diagnostic measure in the old standard of care in detecting precancerous and benign cystic lesions. Patient records over a 15-year period will be reviewed.</description>
  </primary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Pancreatic Neoplasms</condition>
  <condition>Pancreas Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Surgical Tissue Pancreatic cyst fluid&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        As part of standard care, patients will have a consultation (clinic) visit with a&#xD;
        gastroenterologist or surgeon. Patients will be followed per the standard of care at each&#xD;
        institution. There are no required study visits. There will be no blinding performed in&#xD;
        this study. All patients will receive standard (routine) medical care. No placebo or&#xD;
        non-treatment group will be enrolled. There is no treatment failure. Patients will only be&#xD;
        removed from the study if patients request this. When the study ends, or if a patient ends&#xD;
        his or her participation prematurely, all patients will continue to receive medical and/or&#xD;
        surgical care from patients' respective physicians based on currently available published&#xD;
        data and clinical experience.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients age 18 years and older&#xD;
&#xD;
          -  Referred for assessment of a pancreatic cyst.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically ill patients with American Society of Anesthesiologists class 4 or greater.&#xD;
&#xD;
          -  Inability to provide informed consent.&#xD;
&#xD;
          -  Pregnancy or lactation.&#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_official>
    <last_name>Elham Afghani, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elham Afghani, MD MPH</last_name>
    <phone>410-614-6708</phone>
    <email>eafghan1@jhmi.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elham Afghani, MD MPH</last_name>
      <phone>410-614-6708</phone>
      <email>eafghan1@jhmi.edu</email>
    </contact>
    <contact_backup>
      <last_name>Vaishnavi S Sawant, MBBS MPH</last_name>
      <phone>443-603-5875</phone>
      <email>vsawant1@jh.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 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>
    <mesh_term>Pancreatic Cyst</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/NCT04473794
org study id: IRB00249790
secondary id: 5P50CA062924
nct id: NCT04473794
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aims of this study are to determine the natural history of pancreatic cysts and to
      propose and prospectively validate a diagnostic approach and model for prediction of mucinous
      versus non-mucinous, and malignant versus non-malignant, pancreatic cysts using a combination
      of clinical, radiologic, and biomarker characteristics.
Pancreatic cysts are increasingly recognized as incidental lesions due to the widespread use
      of cross-sectional imaging techniques such as CT and MRI. Twenty percent of all pancreatic
      cysts are non-inflammatory cystic neoplasms, many of which are mucinous, and therefore have a
      significant potential for malignant transformation. The primary challenge facing clinicians
      is the inability of current standard diagnostic tests, including imaging and standard
      laboratory data, to accurately and reliably discriminate neoplastic from non-neoplastic, and
      benign from malignant cysts, particularly in patients without symptoms. Therefore, some
      patients with benign cysts undergo unnecessary costly surveillance and possible avoidable
      surgical resections, which is associated with high cost, significant morbidity and mortality,
      while some may not be as aggressively followed. The International Association of
      Pancreatology (IAP) has published guidelines on the management of the two main types of
      mucinous cystic lesions: intraductal papillary mucinous neoplasms (IPMNs) and mucinous cystic
      neoplasms (MCNs). (1) Although these guidelines emphasize the frequency of surveillance and
      outline the indications for resection, these guidelines have not yet been validated, and
      these guidelines presume the diagnosis of a mucinous neoplastic cyst has been confirmed prior
      to surgery. It is unlikely that guidelines that only use clinical and imaging will be able to
      accurately differentiate benign cysts from those that are pre-malignant or currently harbor
      malignancy. Hence, there is a critical need for a diagnostic model that more accurately
      diagnoses neoplastic mucinous and malignant pancreatic cysts as this will improve the
      management of many patients with pancreatic cysts.
observational model: Case-Only
time perspective: Prospective
measure: Clinical utility of Compcyst in pancreatic cysts as assessed by patient chart review
time frame: 15 years
description: Compcyst is part of the new standard of care diagnosis of precancerous and benign cystic lesions. Patient charts will be reviewed for clinical, radiological, surgical and pathologic information (all combined into a composite) that will be used to determine if Compcyst as part of the new standard of care is better than the diagnostic measure in the old standard of care in detecting precancerous and benign cystic lesions. Patient records over a 15-year period will be reviewed.
Blood Surgical Tissue Pancreatic cyst fluid
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elham Afghani, MD MPH
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Elham Afghani, MD MPH
phone: 410-614-6708
email: eafghan1@jhmi.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Pancreatic Cyst