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/NCT05995821</url>
    </required_header>
    <id_info>
      <org_study_id>J1655</org_study_id>
      <secondary_id>IRB00100653</secondary_id>
      <nct_id>NCT05995821</nct_id>
    </id_info>
    <brief_title>Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies</brief_title>
    <official_title>Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Stand Up To Cancer</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</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 research is being done to collect and store biological specimens (biospecimens) from&#xD;
        people with cancer, regardless of tumor type, who are receiving treatments known or thought&#xD;
        to have an effect on the immune system.&#xD;
  &#xD;
        The goal of this discovery and exploratory study is to:&#xD;
  &#xD;
          -  Understand changes in the immune system associated with various cancer treatments, in&#xD;
             order to better design new therapies or tests to predict how these treatments might&#xD;
             work.&#xD;
  &#xD;
          -  Identify risk factors for those who go on to develop side effects from immunotherapy.&#xD;
  &#xD;
        Participants may be asked to:&#xD;
  &#xD;
          -  Donate samples of tumor, blood, lymph nodes, white blood cells, mouth cells (buccal&#xD;
             smears) scraped from the inside of participant's cheek, urine, saliva, or other tissue&#xD;
             samples.&#xD;
  &#xD;
          -  Complete questionnaires about immunotherapy side effects at baseline and with follow-up&#xD;
             appointments.&#xD;
  &#xD;
          -  Undergo knee x-rays.&#xD;
  &#xD;
          -  Allow the use of demographic and clinical information.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies Protocol is&#xD;
        a discovery and exploratory protocol that will enable the investigators to obtain and archive&#xD;
        biological specimens from patients with cancer of the head and neck, thorax and upper&#xD;
        gastrointestinal tract, who are receiving or may receive treatments known or hypothesized to&#xD;
        have an immunomodulatory antitumor effect. The investigators aim to conduct immunologic&#xD;
        studies across tumor types and treatment modalities in order to accomplish the following:&#xD;
  &#xD;
          1. Gain mechanistic insights into the potential influence of various forms of cancer&#xD;
             therapy on antitumor immunity, including but not limited to chemotherapies, kinase&#xD;
             inhibitors, angiogenesis inhibitors, immune-modulating monoclonal antibodies, cellular&#xD;
             immune therapies and radiation therapy.&#xD;
  &#xD;
          2. Define new tumor antigens and the tumor antigens' relevance to disease biology, and&#xD;
             correlate antigen expression with immune responses and disease outcomes.&#xD;
  &#xD;
          3. Evaluate potential immune-related prognostic or treatment response indicators.&#xD;
  &#xD;
          4. Assess the immunologic features of pre-malignant lesions (e.g., atypical or dysplastic&#xD;
             nevi, dysplastic bronchial epithelium, colonic adenomas), and compare these features to&#xD;
             features of invasive cancers.&#xD;
  &#xD;
          5. Investigate the immunobiology of neoadjuvant and adjuvant cancer therapies, including&#xD;
             but not limited to cancer vaccines.&#xD;
  &#xD;
          6. Develop protein-, RNA-, and DNA-based blood markers to monitor tumor burden and predict&#xD;
             and detect tumor relapse.&#xD;
  &#xD;
          7. Evaluate the causative mechanisms of immune-related toxicities in patients receiving&#xD;
             cancer therapy with immune checkpoint blockade.&#xD;
  &#xD;
          8. Characterize factors and molecular pathways in the tumor immune microenvironment that&#xD;
             lead to immune suppression, tolerance to tumor antigens, and cancer progression.&#xD;
  &#xD;
          9. Understand the epidemiology of and risk factors for particular immune related adverse&#xD;
             events (irAEs) including inflammatory arthritis, sicca syndrome and myositis&#xD;
  &#xD;
        To support the above research aims, biological specimens obtained and processed in the&#xD;
        individual laboratories of the co-investigators will be linked by a centralized demographic&#xD;
        database, allowing for the retrieval of information regarding specimen characteristics (e.g.,&#xD;
        tumor type, treatment exposure, date of specimen retrieval, anatomic site of biopsy, biopsy&#xD;
        procedure) and clinical outcomes. Participants starting on immune checkpoint inhibitors will&#xD;
        complete a survey when the participants enroll on study to assess for potential risk factors&#xD;
        for irAE development. Participants will also undergo knee radiographs to evaluate for&#xD;
        osteoarthritis, baseline survey for personal and family historical risk factors, and serial&#xD;
        surveys designed to screen for development of irAEs This information will be correlated with&#xD;
        the results of exploratory scientific analyses conducted in the laboratories of the&#xD;
        co-investigators. Hypotheses generated from this work are expected to support future&#xD;
        hypothesis-driven scientific investigations and clinical trial development.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 25, 2016</start_date>
    <completion_date type="Anticipated">August 25, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 25, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Demographic and clinical data obtained via chart review</measure>
      <time_frame>10 years</time_frame>
      <description>This is a clinic based registry of cancer therapy data from participants to be collected over time.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Biological specimens obtained from cancer patients</measure>
      <time_frame>10 years</time_frame>
      <description>This is a virtual tissue bank containing biological specimens from participants collected over time.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1250</enrollment>
    <condition>Head and Neck Cancer</condition>
    <condition>Lung Cancer</condition>
    <condition>Gastrointestinal Cancer</condition>
    <arm_group>
      <arm_group_label>Upper Aerodigestive Malignancies</arm_group_label>
      <description>Patients with cancer of the head and neck, thorax and upper gastrointestinal tract, who are receiving or may receive treatments known or hypothesized to have an immunomodulatory antitumor effect.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Collection of biological specimens</intervention_name>
      <description>Collection of tumor, blood, lymph nodes, white blood cells, mouth cells (buccal smears) scraped from the inside of your cheek, urine, saliva, or other tissue samples.</description>
      <arm_group_label>Upper Aerodigestive Malignancies</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        -  Tissue Sample Acquisition:&#xD;
  &#xD;
               -  Excess material collected in the course of therapeutic procedures that are&#xD;
                  clinically indicated; or&#xD;
  &#xD;
               -  New biopsies performed for research purposes (e.g., a palpable subcutaneous nodule,&#xD;
                  or a lymph node that is accessible by ultrasound or computed tomography scan&#xD;
                  guidance under local anesthesia).&#xD;
  &#xD;
          -  Blood Sample Acquisition: A peripheral blood sample will be collected from each&#xD;
             participating subject for the isolation and cryopreservation of viable peripheral blood&#xD;
             mononuclear cells, serum, and plasma.&#xD;
  &#xD;
          -  Leukapheresis: patients may undergo pheresis for the purpose of collecting large numbers&#xD;
             of leukocytes for research purposes.&#xD;
  &#xD;
          -  Buccal smears&#xD;
  &#xD;
          -  Bronchoscopy: Endobronchial brushings +/- biopsies&#xD;
  &#xD;
          -  Nasal Epithelium Collection&#xD;
  &#xD;
          -  Expectorated Sputum Collection&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Both men and women and members of all races and ethnic groups are eligible for&#xD;
          participation in this tissue and blood collection protocol. An unlimited number of subjects&#xD;
          may be accrued to this study at the Johns Hopkins University.&#xD;
  &#xD;
          Potential research subjects will be identified by their primary physician/clinical team.&#xD;
          The research subjects will be patients with cancer of the head and neck, thorax and upper&#xD;
          gastrointestinal tract, who are receiving or may receive treatments known or hypothesized&#xD;
          to have an immunomodulatory antitumor effect. The immunologic studies will be conducted&#xD;
          across tumor types and treatment modalities.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects with a pathologically confirmed or clinically suspected upper aerodigestive&#xD;
               malignancy who may be candidates for known or potentially immunomodulating treatments&#xD;
  &#xD;
            -  Ability to understand and willingness to sign a written informed consent document&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with known significant contraindications for venipuncture (e.g., hemoglobin&#xD;
               &lt;8.5 g/dL) will be excluded from the blood collection component of the study&#xD;
  &#xD;
            -  Patients with known significant contraindications for biopsy (e.g., severe bleeding&#xD;
               diathesis) will be excluded from the tissue biopsy component of the study&#xD;
  &#xD;
            -  Patients with known significant contraindications for bronchoscopy (e.g., airway&#xD;
               concerns, significant cardiac disease) will be excluded from the bronchoscopy&#xD;
               component of the study&#xD;
  &#xD;
            -  Unable or unwilling to read English and complete forms/questionnaires&#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>Patrick Forde, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Patrick Forde, MD</last_name>
      <phone>410-955-3974</phone>
      <email>pforde1@jhmi.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Peggy Fitzpatrick, RN</last_name>
      <phone>410-550-5848</phone>
      <email>mfitzpa7@jhmi.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Johns Hopkins University</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21287</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Patrick Forde, MD</last_name>
        <phone>410-955-3974</phone>
        <email>pforde1@jhmi.edu</email>
      </contact>
      <contact_backup>
        <last_name>Peggy Fitzpatrick, RN</last_name>
        <phone>410-550-5848</phone>
        <email>mfitzpa7@jhmi.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Upper Aerodigestive Malignancies</keyword>
    <keyword>Upper Gastrointestinal (GI) Tract</keyword>
    <keyword>Thorax</keyword>
    <keyword>Immunobiology</keyword>
    <keyword>Immunomodulatory</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05995821
  org study id: J1655
  secondary id: IRB00100653
  nct id: NCT05995821
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This research is being done to collect and store biological specimens (biospecimens) from
        people with cancer, regardless of tumor type, who are receiving treatments known or thought
        to have an effect on the immune system.
  
        The goal of this discovery and exploratory study is to:
  
          -  Understand changes in the immune system associated with various cancer treatments, in
             order to better design new therapies or tests to predict how these treatments might
             work.
  
          -  Identify risk factors for those who go on to develop side effects from immunotherapy.
  
        Participants may be asked to:
  
          -  Donate samples of tumor, blood, lymph nodes, white blood cells, mouth cells (buccal
             smears) scraped from the inside of participant's cheek, urine, saliva, or other tissue
             samples.
  
          -  Complete questionnaires about immunotherapy side effects at baseline and with follow-up
             appointments.
  
          -  Undergo knee x-rays.
  
          -  Allow the use of demographic and clinical information.
  The Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies Protocol is
        a discovery and exploratory protocol that will enable the investigators to obtain and archive
        biological specimens from patients with cancer of the head and neck, thorax and upper
        gastrointestinal tract, who are receiving or may receive treatments known or hypothesized to
        have an immunomodulatory antitumor effect. The investigators aim to conduct immunologic
        studies across tumor types and treatment modalities in order to accomplish the following:
  
          1. Gain mechanistic insights into the potential influence of various forms of cancer
             therapy on antitumor immunity, including but not limited to chemotherapies, kinase
             inhibitors, angiogenesis inhibitors, immune-modulating monoclonal antibodies, cellular
             immune therapies and radiation therapy.
  
          2. Define new tumor antigens and the tumor antigens' relevance to disease biology, and
             correlate antigen expression with immune responses and disease outcomes.
  
          3. Evaluate potential immune-related prognostic or treatment response indicators.
  
          4. Assess the immunologic features of pre-malignant lesions (e.g., atypical or dysplastic
             nevi, dysplastic bronchial epithelium, colonic adenomas), and compare these features to
             features of invasive cancers.
  
          5. Investigate the immunobiology of neoadjuvant and adjuvant cancer therapies, including
             but not limited to cancer vaccines.
  
          6. Develop protein-, RNA-, and DNA-based blood markers to monitor tumor burden and predict
             and detect tumor relapse.
  
          7. Evaluate the causative mechanisms of immune-related toxicities in patients receiving
             cancer therapy with immune checkpoint blockade.
  
          8. Characterize factors and molecular pathways in the tumor immune microenvironment that
             lead to immune suppression, tolerance to tumor antigens, and cancer progression.
  
          9. Understand the epidemiology of and risk factors for particular immune related adverse
             events (irAEs) including inflammatory arthritis, sicca syndrome and myositis
  
        To support the above research aims, biological specimens obtained and processed in the
        individual laboratories of the co-investigators will be linked by a centralized demographic
        database, allowing for the retrieval of information regarding specimen characteristics (e.g.,
        tumor type, treatment exposure, date of specimen retrieval, anatomic site of biopsy, biopsy
        procedure) and clinical outcomes. Participants starting on immune checkpoint inhibitors will
        complete a survey when the participants enroll on study to assess for potential risk factors
        for irAE development. Participants will also undergo knee radiographs to evaluate for
        osteoarthritis, baseline survey for personal and family historical risk factors, and serial
        surveys designed to screen for development of irAEs This information will be correlated with
        the results of exploratory scientific analyses conducted in the laboratories of the
        co-investigators. Hypotheses generated from this work are expected to support future
        hypothesis-driven scientific investigations and clinical trial development.
  observational model: Other
  time perspective: Prospective
  measure: Demographic and clinical data obtained via chart review
  time frame: 10 years
  description: This is a clinic based registry of cancer therapy data from participants to be collected over time.
  measure: Biological specimens obtained from cancer patients
  time frame: 10 years
  description: This is a virtual tissue bank containing biological specimens from participants collected over time.
  arm group label: Upper Aerodigestive Malignancies
  description: Patients with cancer of the head and neck, thorax and upper gastrointestinal tract, who are receiving or may receive treatments known or hypothesized to have an immunomodulatory antitumor effect.
  intervention type: Other
  intervention name: Collection of biological specimens
  description: Collection of tumor, blood, lymph nodes, white blood cells, mouth cells (buccal smears) scraped from the inside of your cheek, urine, saliva, or other tissue samples.
  arm group label: Upper Aerodigestive Malignancies
  -  Tissue Sample Acquisition:
  
               -  Excess material collected in the course of therapeutic procedures that are
                  clinically indicated; or
  
               -  New biopsies performed for research purposes (e.g., a palpable subcutaneous nodule,
                  or a lymph node that is accessible by ultrasound or computed tomography scan
                  guidance under local anesthesia).
  
          -  Blood Sample Acquisition: A peripheral blood sample will be collected from each
             participating subject for the isolation and cryopreservation of viable peripheral blood
             mononuclear cells, serum, and plasma.
  
          -  Leukapheresis: patients may undergo pheresis for the purpose of collecting large numbers
             of leukocytes for research purposes.
  
          -  Buccal smears
  
          -  Bronchoscopy: Endobronchial brushings +/- biopsies
  
          -  Nasal Epithelium Collection
  
          -  Expectorated Sputum Collection
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Patrick Forde, MD
  role: Principal Investigator
  affiliation: Johns Hopkins University
  last name: Patrick Forde, MD
  phone: 410-955-3974
  email: pforde1@jhmi.edu
  last name: Peggy Fitzpatrick, RN
  phone: 410-550-5848
  email: mfitzpa7@jhmi.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Gastrointestinal Neoplasms
  sharing ipd: No