<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/NCT04450927</url>
  </required_header>
  <id_info>
    <org_study_id>200099</org_study_id>
    <secondary_id>20-H-0099</secondary_id>
    <nct_id>NCT04450927</nct_id>
  </id_info>
  <brief_title>Data Collection of Standard Care and Evaluation of NHLBI Patients and Donors</brief_title>
  <official_title>Data Collection of Standard Care and Evaluation of NHLBI Patients and Donors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</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>
      Background:&#xD;
&#xD;
      Researchers seek ways to study people s medical problems in order to teach and further&#xD;
      general knowledge. The ability to assess and treat people with a wide range of diseases is&#xD;
      critical to training people to be good doctors. It is also needed to keep medical staff up to&#xD;
      date. In this study, researchers want to study the course of some illnesses to learn more&#xD;
      about them. To do this, they will collect and review people s medical records. In some cases,&#xD;
      they may also provide treatment.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To collect data that may be used to help researchers create ideas for future research.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People age 2 and older who have or are suspected to have a medical condition for which they&#xD;
      have been referred to NIH s National Heart, Lung, and Blood Institute, as well as stem cell&#xD;
      donors&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants may be screened with a review of the following:&#xD;
&#xD;
      Medical records&#xD;
&#xD;
      Scans and images&#xD;
&#xD;
      Other existing samples and reports.&#xD;
&#xD;
      Participants medical data will be collected from the standard care they receive. This&#xD;
      includes their routine blood and urine tests, X-rays and scans, and other tests to diagnose&#xD;
      or follow their medical condition. Data will also be collected from the treatments they may&#xD;
      receive. For stem cell donors, data from apheresis procedures will be collected. Demographic&#xD;
      data will also be collected.&#xD;
&#xD;
      All of the data will be kept in the medical records or on secure network drives.&#xD;
&#xD;
      Some participants may need to be treated for their medical condition. If so, they will sign a&#xD;
      separate consent form for that treatment.&#xD;
&#xD;
      Participation lasts up to 2 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This protocol is designed to provide a repository of information to allow for hypothesis&#xD;
      generation in future research. This information will be drawn from standard medical&#xD;
      care/procedures and follow up of patients and healthy volunteers, including transplant&#xD;
      donors, who are not currently receiving therapy on an active NHLBI research protocol. It&#xD;
      allows investigation into the problems of these patients for the purpose of teaching and&#xD;
      furthering general knowledge. The ability to evaluate and treat patients with a wide variety&#xD;
      of diseases is critical to maintaining our accreditation with the hematology-oncology,&#xD;
      cardiology, and pulmonary fellowship programs and training our fellows to be competent&#xD;
      physicians, as well as for keeping all staff, including senior staff, up-to-date and familiar&#xD;
      with the evaluation and treatment of patients with a wide spectrum of diseases. Periodic&#xD;
      follow-up and treatment of patients previously entered on NHLBI protocols in order to monitor&#xD;
      the long-term course of the underlying disease and the consequences of experimental&#xD;
      treatments is also required for fellowship training, and for maintenance of good referral&#xD;
      relationships with patients and their physicians. This study also allows for standard&#xD;
      apheresis procedures for transplant donors and for care of volunteers who may present with a&#xD;
      treatable condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2040</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2040</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To provide a repository of information on enrolled participants to allow for hypothesis generation in future research</measure>
    <time_frame>20 years</time_frame>
    <description>To provide a repository of information on enrolled participants to allow for hypothesis generation in future research</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To add value to the NHLBI training program</measure>
    <time_frame>20 years</time_frame>
    <description>To add value to the NHLBI training program by providing consult, treatment, diagnostic tests, and medical follow-up of participants</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Wide Spectrum of Diseases</condition>
  <condition>Hematologic Diseases</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>Data collection and treatment according to guidelines of standard of medical evaluation and care. No investigational treatments or procedures will be administered on this protocol.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects 2 or older and weighing greater than 12 kg, who meet inclusion criteria will&#xD;
        be considered for participation on this protocol at this discretion of the Principal or&#xD;
        Associate Investigator&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  ELIGIBILITY:&#xD;
&#xD;
               1. Patients (including those referred to us to rule out a disease or condition) and&#xD;
                  stem cell donors,&#xD;
&#xD;
                  may be entered on this protocol at the discretion of the Principal and/or&#xD;
                  Associate Investigators.&#xD;
&#xD;
               2. The patient or the patient's Legally Authorized Representative is capable of&#xD;
                  informed consent and&#xD;
&#xD;
                  signs the consent form. The consent form will be signed by parents or guardians&#xD;
                  of patients under&#xD;
&#xD;
                  the age of 18.&#xD;
&#xD;
               3. Age more than or equal to 2 and weight &gt; 12 kg&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georg Aue, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Heart, Lung, and Blood Institute (NHLBI)</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?A_2020-H-0099.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>July 6, 2023</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Repository</keyword>
  <keyword>Hematology</keyword>
  <keyword>Cardiology</keyword>
  <keyword>Pulmonary</keyword>
  <keyword>Oncology</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04450927
org study id: 200099
secondary id: 20-H-0099
nct id: NCT04450927
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      Researchers seek ways to study people s medical problems in order to teach and further
      general knowledge. The ability to assess and treat people with a wide range of diseases is
      critical to training people to be good doctors. It is also needed to keep medical staff up to
      date. In this study, researchers want to study the course of some illnesses to learn more
      about them. To do this, they will collect and review people s medical records. In some cases,
      they may also provide treatment.

      Objective:

      To collect data that may be used to help researchers create ideas for future research.

      Eligibility:

      People age 2 and older who have or are suspected to have a medical condition for which they
      have been referred to NIH s National Heart, Lung, and Blood Institute, as well as stem cell
      donors

      Design:

      Participants may be screened with a review of the following:

      Medical records

      Scans and images

      Other existing samples and reports.

      Participants medical data will be collected from the standard care they receive. This
      includes their routine blood and urine tests, X-rays and scans, and other tests to diagnose
      or follow their medical condition. Data will also be collected from the treatments they may
      receive. For stem cell donors, data from apheresis procedures will be collected. Demographic
      data will also be collected.

      All of the data will be kept in the medical records or on secure network drives.

      Some participants may need to be treated for their medical condition. If so, they will sign a
      separate consent form for that treatment.

      Participation lasts up to 2 years.
This protocol is designed to provide a repository of information to allow for hypothesis
      generation in future research. This information will be drawn from standard medical
      care/procedures and follow up of patients and healthy volunteers, including transplant
      donors, who are not currently receiving therapy on an active NHLBI research protocol. It
      allows investigation into the problems of these patients for the purpose of teaching and
      furthering general knowledge. The ability to evaluate and treat patients with a wide variety
      of diseases is critical to maintaining our accreditation with the hematology-oncology,
      cardiology, and pulmonary fellowship programs and training our fellows to be competent
      physicians, as well as for keeping all staff, including senior staff, up-to-date and familiar
      with the evaluation and treatment of patients with a wide spectrum of diseases. Periodic
      follow-up and treatment of patients previously entered on NHLBI protocols in order to monitor
      the long-term course of the underlying disease and the consequences of experimental
      treatments is also required for fellowship training, and for maintenance of good referral
      relationships with patients and their physicians. This study also allows for standard
      apheresis procedures for transplant donors and for care of volunteers who may present with a
      treatable condition.
observational model: Case-Only
time perspective: Cross-Sectional
measure: To provide a repository of information on enrolled participants to allow for hypothesis generation in future research
time frame: 20 years
description: To provide a repository of information on enrolled participants to allow for hypothesis generation in future research
measure: To add value to the NHLBI training program
time frame: 20 years
description: To add value to the NHLBI training program by providing consult, treatment, diagnostic tests, and medical follow-up of participants
arm group label: 1
description: Data collection and treatment according to guidelines of standard of medical evaluation and care. No investigational treatments or procedures will be administered on this protocol.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 120 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Georg Aue, M.D.
role: Principal Investigator
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2020-H-0099.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: Hematologic Diseases
sharing ipd: Undecided