<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/NCT04428918</url>
  </required_header>
  <id_info>
    <org_study_id>200072</org_study_id>
    <secondary_id>20-C-0072</secondary_id>
    <nct_id>NCT04428918</nct_id>
  </id_info>
  <brief_title>Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation</brief_title>
  <official_title>Biospecimen Procurement for Immunological Landscape Studies Following Hematopoietic Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Allogenic hematopoietic cell transplantation (HCT) is a procedure in which a person gets stem&#xD;
      cells from a donor in order to treat their disease. Researchers want to collect samples from&#xD;
      people who have had or will have HCT. They will perform tests on the samples to study the&#xD;
      immune system and its response to infections and disease.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To collect biological samples from people who have had or are planning to have HCT to treat&#xD;
      primary immunodeficiencies, blood cancers, or disorders of T-cell proliferation and/or&#xD;
      dysregulation.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People age 8 years and older who have undergone or are planning to undergo HCT.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with:&#xD;
&#xD;
      Medical history&#xD;
&#xD;
      Medical chart review&#xD;
&#xD;
      Physical exam&#xD;
&#xD;
      Blood tests.&#xD;
&#xD;
      Participants may give blood and urine samples.&#xD;
&#xD;
      Participants may have a skin biopsy.&#xD;
&#xD;
      Participants may undergo apheresis. For this, a needle will be placed into an arm vein to&#xD;
      take blood. A machine divides the whole blood into parts. The sample cells are taken out and&#xD;
      the rest of the blood is returned through a second needle in the other arm.&#xD;
&#xD;
      Participants may have a bone marrow aspiration and biopsy. For this, the hipbone will be&#xD;
      numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the&#xD;
      needle.&#xD;
&#xD;
      Participants may have a tumor or other abnormal tissue biopsy. For this, a tissue sample is&#xD;
      obtained using a needle and syringe. They will sign a separate consent form. They may have a&#xD;
      body scan or ultrasound to help locate the tumor during the biopsy.&#xD;
&#xD;
      Participation lasts for as long as participants choose to give samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
        -  Allogenic Hematopoietic Cell Transplantation (HCT) is a potentially curative option for&#xD;
           some patients with primary immunodeficiencies (PID) and hematological cancers.&#xD;
&#xD;
        -  HCT for PID looks to restore defects in cells of hematopoietic origin allowing for&#xD;
           eradication of protracted or recurrent viral infections.&#xD;
&#xD;
        -  The curative potential of allogenic HCT for hematologic malignancies is mediated by the&#xD;
           allogeneic immune system through a graft-versus-tumor (GVT) effect.&#xD;
&#xD;
        -  Characterization of the immunologic landscape in patients with successful eradication of&#xD;
           viral infections and hematologic malignancies following allogenic HCT requires further&#xD;
           investigation.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      -To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens&#xD;
      from patients with allogenic HCT and perform immunological landscape studies.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      -Patients age greater than or equal to 8 years of age and have undergone or are planning to&#xD;
      undergo HCT.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Up to 100 subjects will be enrolled.&#xD;
&#xD;
        -  Patients may undergo sampling of blood, apheresis products, tumor, effusions, ascites,&#xD;
           urine, bone marrow, skin, mucosa, saliva, stool, sputum, spinal fluid, or other tissues&#xD;
           or fluids for banking and laboratory studies.&#xD;
&#xD;
        -  No investigational or experimental therapy will be given as part of this protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study was closed due to investigator discretion based on the lack of ability to recruit&#xD;
    patients and research goals of the program.&#xD;
  </why_stopped>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Actual">September 17, 2020</completion_date>
  <primary_completion_date type="Actual">September 17, 2020</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Sample Aquisition</measure>
    <time_frame>Ongoing</time_frame>
    <description>To conduct immunological landscape studies on samples collected. To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with allogenic HCT.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Hematopoietic Stem Cell Transplantation</condition>
  <condition>Cell Transplantation</condition>
  <condition>Hematologic Malignancies</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>Allogeneic HCT recipient or patient pending receipt of HCT</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients age &gt; 8 years of age and have undergone or are planning to undergo HCT.&#xD;
        Participants are selected from other NIH protocols (including screening protocols) they may&#xD;
        be co-enrolled on and can include both inpatient and outpatient.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Diagnosis of a hematologic malignancy, immunodeficiency or disorder of T-cell&#xD;
             proliferation and/or dysregulation&#xD;
&#xD;
          -  Have undergone or planning to undergo an allogenic hematopoietic cell transplantation&#xD;
&#xD;
          -  Age greater than or equal to 8 years&#xD;
&#xD;
          -  Additional inclusion criteria pertinent only for patients undergoing apheresis&#xD;
&#xD;
          -  Hemoglobin greater than or equal to 8 mg/dL and platelet count &gt; 75 K/uL&#xD;
&#xD;
          -  Weight greater than or equal to 48 kg&#xD;
&#xD;
          -  Adequate venous access&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Active concomitant medical or psychological illnesses that may increase the risk to&#xD;
             the subject&#xD;
&#xD;
          -  Inability of subject or parent/legal guardian to provide informed consent&#xD;
&#xD;
          -  Pregnant or breastfeeding women as some tests and procedures allowed are&#xD;
             contraindicated in pregnancy (i.e., CT scans, administration of iodinated contrast)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian S Hinrichs, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2020-C-0072.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunological</keyword>
  <keyword>Apheresis Products</keyword>
  <keyword>Protein</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</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/NCT04428918
org study id: 200072
secondary id: 20-C-0072
nct id: NCT04428918
lead sponsor: 
Background:

      Allogenic hematopoietic cell transplantation (HCT) is a procedure in which a person gets stem
      cells from a donor in order to treat their disease. Researchers want to collect samples from
      people who have had or will have HCT. They will perform tests on the samples to study the
      immune system and its response to infections and disease.

      Objective:

      To collect biological samples from people who have had or are planning to have HCT to treat
      primary immunodeficiencies, blood cancers, or disorders of T-cell proliferation and/or
      dysregulation.

      Eligibility:

      People age 8 years and older who have undergone or are planning to undergo HCT.

      Design:

      Participants will be screened with:

      Medical history

      Medical chart review

      Physical exam

      Blood tests.

      Participants may give blood and urine samples.

      Participants may have a skin biopsy.

      Participants may undergo apheresis. For this, a needle will be placed into an arm vein to
      take blood. A machine divides the whole blood into parts. The sample cells are taken out and
      the rest of the blood is returned through a second needle in the other arm.

      Participants may have a bone marrow aspiration and biopsy. For this, the hipbone will be
      numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the
      needle.

      Participants may have a tumor or other abnormal tissue biopsy. For this, a tissue sample is
      obtained using a needle and syringe. They will sign a separate consent form. They may have a
      body scan or ultrasound to help locate the tumor during the biopsy.

      Participation lasts for as long as participants choose to give samples.
Background:

        -  Allogenic Hematopoietic Cell Transplantation (HCT) is a potentially curative option for
           some patients with primary immunodeficiencies (PID) and hematological cancers.

        -  HCT for PID looks to restore defects in cells of hematopoietic origin allowing for
           eradication of protracted or recurrent viral infections.

        -  The curative potential of allogenic HCT for hematologic malignancies is mediated by the
           allogeneic immune system through a graft-versus-tumor (GVT) effect.

        -  Characterization of the immunologic landscape in patients with successful eradication of
           viral infections and hematologic malignancies following allogenic HCT requires further
           investigation.

      Objectives:

      -To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens
      from patients with allogenic HCT and perform immunological landscape studies.

      Eligibility:

      -Patients age greater than or equal to 8 years of age and have undergone or are planning to
      undergo HCT.

      Design:

        -  Up to 100 subjects will be enrolled.

        -  Patients may undergo sampling of blood, apheresis products, tumor, effusions, ascites,
           urine, bone marrow, skin, mucosa, saliva, stool, sputum, spinal fluid, or other tissues
           or fluids for banking and laboratory studies.

        -  No investigational or experimental therapy will be given as part of this protocol.
observational model: Cohort
time perspective: Prospective
measure: Sample Aquisition
time frame: Ongoing
description: To conduct immunological landscape studies on samples collected. To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with allogenic HCT.
arm group label: Cohort 1
description: Allogeneic HCT recipient or patient pending receipt of HCT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: No
last name: Christian S Hinrichs, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2020-C-0072.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: Hematologic Neoplasms