<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/NCT03278912</url>
  </required_header>
  <id_info>
    <org_study_id>170163</org_study_id>
    <secondary_id>17-I-0163</secondary_id>
    <nct_id>NCT03278912</nct_id>
  </id_info>
  <brief_title>Natural History of Intestinal Inflammation in People With Primary Immune Dysregulations</brief_title>
  <official_title>Natural History of Intestinal Inflammation in Patients With Primary Immune Dysregulations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</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;
      PIDD stands for primary immune dysregulation. It is a general term that includes many&#xD;
      different inherited immune system disorders. The immune system is the part of the body that&#xD;
      helps fight disease and infection. People with PIDDs can develop many kinds of health&#xD;
      problems. One of these is inflammatory bowel disease (IBD), which causes diarrhea and&#xD;
      cramping. Researchers want to learn more about these disorders to develop possible&#xD;
      treatments.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To learn more about when and why IBD may develop in some people with PIDDs.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People ages 3 and older who have PIDD or IBD.&#xD;
&#xD;
      Healthy volunteers in this age group are also needed.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Visit 1: Participants will be screened with physical exam, medical history, and blood and&#xD;
      urine tests.&#xD;
&#xD;
      Visit 2: Participants will:&#xD;
&#xD;
        -  Have more physical exams and blood and urine tests.&#xD;
&#xD;
        -  Answer questions about quality of life and food history.&#xD;
&#xD;
        -  Provide a stool sample.&#xD;
&#xD;
        -  Have nasal and rectal skin swabs.&#xD;
&#xD;
        -  Have saliva collected.&#xD;
&#xD;
      Participants will have 1 follow-up visit per year. They will repeat visit 2 procedures.&#xD;
&#xD;
      Participants will be contacted by phone or email in between yearly visits. They will be asked&#xD;
      about their health. They will complete a quality-of-life questionnaire and send a stool&#xD;
      sample that is collected at home.&#xD;
&#xD;
      If participants experience a sudden change in symptoms or undergo a new treatment, they may&#xD;
      be asked to complete visit 2 procedures.&#xD;
&#xD;
      If participants are not able to come to NIH, study data and samples can be collected without&#xD;
      an in-person visit.&#xD;
&#xD;
      Participants will have a final study visit about 10 years after Visit 1. They will repeat&#xD;
      visit 2 procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over 1 million people suffer from IBD in the United States. Although the exact pathogenesis&#xD;
      is unclear, IBD results from an inappropriate inflammatory response to intestinal microbes&#xD;
      which is influenced by the environment in a genetically susceptible host. IBDs can be&#xD;
      classified as conventional (Crohn disease (CD) and ulcerative colitis (UC)) and unclassified&#xD;
      (early onset, difficult to treat, associated with monogenic disorders and PIDDs). Among the&#xD;
      200 IBD susceptibility loci identified in genome-wide association studies (GWAS), overlap&#xD;
      with aberrations identified in PIDDs has been observed, thereby supporting the study of PIDDs&#xD;
      to better understand conventional IBD pathogenesis, while recognizing PIDD-associated IBDs as&#xD;
      distinct disease entities requiring specialized management.&#xD;
&#xD;
      The prevalence of PIDDs worldwide is estimated at 1 in 2000 live births and encompasses a&#xD;
      growing list of over 300 PIDDs. Despite the fact that GI disease is the second most common&#xD;
      complication in patients with PIDDs (rates ranging from 5-50%), little is known about&#xD;
      PIDDspecific&#xD;
&#xD;
      IBD pathogenesis and even less is understood about the role of the microbiota both as a&#xD;
      consequence and modulator of immune response in these inherited disorders. Moreover, there&#xD;
      may be a time-limited period (&quot;immunological window of opportunity&quot;), coinciding with the&#xD;
      maturation of the host s microbiome, during which early immune education may have long-term&#xD;
      effects on predisposition to aberrant immune responses and inflammatory dysregulation. The&#xD;
      primary objective of this study is to determine if PIDDs result in intestinal dysbioses,&#xD;
      which alter local and systemic immune responses. Our long-term goal is to comprehensively&#xD;
      investigate the immunological window of opportunity as it relates to PIDD-associated IBDs to&#xD;
      define time-sensitive immunoregulatory targets for therapeutic intervention. We will pursue&#xD;
      this goal through a prospective, longitudinal study of pediatric and adult patients with&#xD;
      PIDDs (with and without IBD) before and after treatment and/or diagnostic interventions,&#xD;
      including but not limited to hematopoietic stem cell transplantation (HSCT). Findings from&#xD;
      subjects with PIDDs will be compared to those from subjects with IBD as well as healthy&#xD;
      volunteers. This multifaceted study will complement primary patient protocols while allowing&#xD;
      for the direct interrogation of specific arms of innate and adaptive immunity in the context&#xD;
      of host-microbiome interactions. Patients will be studied over time through the collection of&#xD;
      clinical metadata, blood, stool, urine, saliva, skin swabs, and biopsies obtained from&#xD;
      clinically-indicated endoscopies in age-appropriate patients. PIDDs of interest include but&#xD;
      are not limited to: CGD, CTLA4 and LRBA protein deficiency, hypomorphic RAG deficiency, and&#xD;
      IPEX syndrome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding completed.&#xD;
  </why_stopped>
  <start_date type="Actual">September 8, 2023</start_date>
  <completion_date type="Actual">September 8, 2023</completion_date>
  <primary_completion_date type="Actual">September 8, 2023</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>Disease-specific intestinal microbiome signatures, and related localized and systemic immune responses.</measure>
    <time_frame>Baseline and Annual follow-up visits spanning 10 years</time_frame>
    <description>1. Microbiome, metabolomics, and transcriptomic signatures will be examined between comparison groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in microbiome signatures. Changes in metabolomic and transcriptomic signatures.</measure>
    <time_frame>Baseline and Annual follow-up visits spanning 10 years</time_frame>
    <description>1. Microbiome, metabolomics, and transcriptomic signatures will be examined between comparison groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in systemic and tissue-specific markers of innate and adaptive immunity.</measure>
    <time_frame>Baseline and Annual follow-up visits spanning 10 years</time_frame>
    <description>2. For evaluation of markers of innate and adaptive immunity (local and systemic) most comparisons will be made using 2-tailed Student t tests with statistical significance set at a p less than or equal to 0.05.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-specific differences in relative quantity and function of peripheral blood and tissue immune cells (includes hematopoietic and stromal cells).</measure>
    <time_frame>Throughout length of study</time_frame>
    <description>3. For evaluation of disease-specific differences in relative quantity and function of peripheral blood and tissue immune cells most comparisons will be made using 2-tailed Student t tests with statistical significance set at a p less than or equal to 0.05.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Granulomatous Disease</condition>
  <condition>Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>IBD</arm_group_label>
    <description>-Patients with IBD without a diagnosed PIDD.-First- or second-degree relatives of patients with a PIDD of interest who do not have a PIDD themselves, but have diagnosed or suspected IBD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-PIDD/non-IBD (healthy volunteers)</arm_group_label>
    <description>healthy volunteers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PIDD</arm_group_label>
    <description>CGD cohort; IPEX syndrome cohort; CTLA4 haploinsufficiency cohort; LRBA deficiency and hypomorphic RAG deficiency cohorts</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include patients and healthy volunteers greater than or equal to&#xD;
        3 years of age; PIDDs of interest, IBD, and Non-PIDD/non-IBD (healthy volunteers)@@@@@@&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  General Inclusion Criteria - All individuals must meet the following criteria to be&#xD;
             eligible for study participation:&#xD;
&#xD;
               -  Age greater than or equal to 3 years.&#xD;
&#xD;
               -  Willing to allow storage of samples for future research.&#xD;
&#xD;
               -  Willing to allow genetic testing of their samples.&#xD;
&#xD;
               -  Negative urine or serum pregnancy test for women of childbearing potential.&#xD;
&#xD;
          -  Specific Inclusion Criteria for PIDD of Interest Cohort: Enrollment as a patient with&#xD;
             confirmed PIDD or carrier status in a current NIH protocol, regardless of an IBD&#xD;
             component.&#xD;
&#xD;
          -  Specific Inclusion Criteria for IBD Cohort:&#xD;
&#xD;
               -  Enrollment as a patient with confirmed IBD in a current NIH protocol.&#xD;
&#xD;
               -  Absence of clinical findings or history suggestive of a primary or acquired&#xD;
                  immunodeficiency (not including immunodeficiency caused by certain IBD&#xD;
                  treatments).&#xD;
&#xD;
          -  Specific Inclusion Criteria for non-PIDD/non-IBD Cohort (Healthy Volunteers):&#xD;
&#xD;
               -  Absence of clinical findings or history suggestive of a primary or acquired&#xD;
                  immunodeficiency.&#xD;
&#xD;
               -  Absence of clinical findings or history suggestive of IBD.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  General Exclusion Criteria - An individual who meets any of the following criteria&#xD;
             will be excluded from study participation:&#xD;
&#xD;
               -  Active malignancy requiring treatment.&#xD;
&#xD;
               -  HIV.&#xD;
&#xD;
               -  Current treatment for hepatitis B.&#xD;
&#xD;
               -  Current treatment for hepatitis C.&#xD;
&#xD;
               -  Recreational IV drug use within the past 6 months (based on subject report).&#xD;
&#xD;
               -  Participation in a research study of an investigational vaccine within the past 6&#xD;
                  months.&#xD;
&#xD;
               -  Any condition that, in the opinion of the investigator, contraindicates&#xD;
                  participation in this study.&#xD;
&#xD;
          -  Specific Exclusion Criteria for PIDD of Interest Cohort: None.&#xD;
&#xD;
          -  Specific Exclusion Criteria for IBD Cohort: None.&#xD;
&#xD;
          -  Specific Exclusion Criteria for non-PIDD/non-IBD Cohort (Healthy Volunteers):&#xD;
&#xD;
               -  Treatment with systemic antimicrobials within the past 3 months, unless it is a&#xD;
                  prophylactic regimen consisting of either an azole ,&#xD;
                  trimethoprim-sulfamethoxazole, a quinolone, or any antimicrobial regimen&#xD;
                  resembling a typical prophylaxis regimen used to treat a PIDD of interest.&#xD;
&#xD;
               -  Treatment with immune modulators within the past 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christa S Zerbe, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Allergy and Infectious Diseases (NIAID)</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_2017-I-0163.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Agarwal S, Mayer L. Gastrointestinal manifestations in primary immune disorders. Inflamm Bowel Dis. 2010 Apr;16(4):703-11. doi: 10.1002/ibd.21040.</citation>
    <PMID>19637385</PMID>
  </reference>
  <reference>
    <citation>Marciano BE, Rosenzweig SD, Kleiner DE, Anderson VL, Darnell DN, Anaya-O'Brien S, Hilligoss DM, Malech HL, Gallin JI, Holland SM. Gastrointestinal involvement in chronic granulomatous disease. Pediatrics. 2004 Aug;114(2):462-8. doi: 10.1542/peds.114.2.462.</citation>
    <PMID>15286231</PMID>
  </reference>
  <reference>
    <citation>Uhlig HH. Monogenic diseases associated with intestinal inflammation: implications for the understanding of inflammatory bowel disease. Gut. 2013 Dec;62(12):1795-805. doi: 10.1136/gutjnl-2012-303956.</citation>
    <PMID>24203055</PMID>
  </reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inflammatory Bowel Disease</keyword>
  <keyword>Chronic Granulomatous Disease</keyword>
  <keyword>Dysbiosis</keyword>
  <keyword>Microbiome</keyword>
  <keyword>Immunodeficiency</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Granulomatous Disease, Chronic</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>.The following will be shared:@@@@@@ (Summation)De-identified data in an NIH-funded or approved public repository.@@@@@@ (Summation)Identified data in the Biomedical Translational Research Information System (BTRIS).@@@@@@.De-identified or identified data with approved NIH-based and/or outside collaborators under appropriate agreements.</ipd_description>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be shared before publication, at publication or shortly after publication.</ipd_time_frame>
    <ipd_access_criteria>Data will be shared through:@@@@@@ (Summation)An NIH-funded or approved public repository: National Center for Biotechnology Information Sequence Read Archive (NCBI SRA) Database.@@@@@@ (Summation)BTRIS.@@@@@@ (Summation)Approved outside collaborators under appropriate individual agreements.@@@@@@ (Summation)Publication and/or public presentations.@@@@@@The PI will review and approve/disapprove requests for IDP.</ipd_access_criteria>
  </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/NCT03278912
org study id: 170163
secondary id: 17-I-0163
nct id: NCT03278912
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      PIDD stands for primary immune dysregulation. It is a general term that includes many
      different inherited immune system disorders. The immune system is the part of the body that
      helps fight disease and infection. People with PIDDs can develop many kinds of health
      problems. One of these is inflammatory bowel disease (IBD), which causes diarrhea and
      cramping. Researchers want to learn more about these disorders to develop possible
      treatments.

      Objective:

      To learn more about when and why IBD may develop in some people with PIDDs.

      Eligibility:

      People ages 3 and older who have PIDD or IBD.

      Healthy volunteers in this age group are also needed.

      Design:

      Visit 1: Participants will be screened with physical exam, medical history, and blood and
      urine tests.

      Visit 2: Participants will:

        -  Have more physical exams and blood and urine tests.

        -  Answer questions about quality of life and food history.

        -  Provide a stool sample.

        -  Have nasal and rectal skin swabs.

        -  Have saliva collected.

      Participants will have 1 follow-up visit per year. They will repeat visit 2 procedures.

      Participants will be contacted by phone or email in between yearly visits. They will be asked
      about their health. They will complete a quality-of-life questionnaire and send a stool
      sample that is collected at home.

      If participants experience a sudden change in symptoms or undergo a new treatment, they may
      be asked to complete visit 2 procedures.

      If participants are not able to come to NIH, study data and samples can be collected without
      an in-person visit.

      Participants will have a final study visit about 10 years after Visit 1. They will repeat
      visit 2 procedures.
Over 1 million people suffer from IBD in the United States. Although the exact pathogenesis
      is unclear, IBD results from an inappropriate inflammatory response to intestinal microbes
      which is influenced by the environment in a genetically susceptible host. IBDs can be
      classified as conventional (Crohn disease (CD) and ulcerative colitis (UC)) and unclassified
      (early onset, difficult to treat, associated with monogenic disorders and PIDDs). Among the
      200 IBD susceptibility loci identified in genome-wide association studies (GWAS), overlap
      with aberrations identified in PIDDs has been observed, thereby supporting the study of PIDDs
      to better understand conventional IBD pathogenesis, while recognizing PIDD-associated IBDs as
      distinct disease entities requiring specialized management.

      The prevalence of PIDDs worldwide is estimated at 1 in 2000 live births and encompasses a
      growing list of over 300 PIDDs. Despite the fact that GI disease is the second most common
      complication in patients with PIDDs (rates ranging from 5-50%), little is known about
      PIDDspecific

      IBD pathogenesis and even less is understood about the role of the microbiota both as a
      consequence and modulator of immune response in these inherited disorders. Moreover, there
      may be a time-limited period ("immunological window of opportunity"), coinciding with the
      maturation of the host s microbiome, during which early immune education may have long-term
      effects on predisposition to aberrant immune responses and inflammatory dysregulation. The
      primary objective of this study is to determine if PIDDs result in intestinal dysbioses,
      which alter local and systemic immune responses. Our long-term goal is to comprehensively
      investigate the immunological window of opportunity as it relates to PIDD-associated IBDs to
      define time-sensitive immunoregulatory targets for therapeutic intervention. We will pursue
      this goal through a prospective, longitudinal study of pediatric and adult patients with
      PIDDs (with and without IBD) before and after treatment and/or diagnostic interventions,
      including but not limited to hematopoietic stem cell transplantation (HSCT). Findings from
      subjects with PIDDs will be compared to those from subjects with IBD as well as healthy
      volunteers. This multifaceted study will complement primary patient protocols while allowing
      for the direct interrogation of specific arms of innate and adaptive immunity in the context
      of host-microbiome interactions. Patients will be studied over time through the collection of
      clinical metadata, blood, stool, urine, saliva, skin swabs, and biopsies obtained from
      clinically-indicated endoscopies in age-appropriate patients. PIDDs of interest include but
      are not limited to: CGD, CTLA4 and LRBA protein deficiency, hypomorphic RAG deficiency, and
      IPEX syndrome.
observational model: Cohort
time perspective: Prospective
measure: Disease-specific intestinal microbiome signatures, and related localized and systemic immune responses.
time frame: Baseline and Annual follow-up visits spanning 10 years
description: 1. Microbiome, metabolomics, and transcriptomic signatures will be examined between comparison groups.
measure: Changes in microbiome signatures. Changes in metabolomic and transcriptomic signatures.
time frame: Baseline and Annual follow-up visits spanning 10 years
description: 1. Microbiome, metabolomics, and transcriptomic signatures will be examined between comparison groups.
measure: Changes in systemic and tissue-specific markers of innate and adaptive immunity.
time frame: Baseline and Annual follow-up visits spanning 10 years
description: 2. For evaluation of markers of innate and adaptive immunity (local and systemic) most comparisons will be made using 2-tailed Student t tests with statistical significance set at a p less than or equal to 0.05.
measure: Disease-specific differences in relative quantity and function of peripheral blood and tissue immune cells (includes hematopoietic and stromal cells).
time frame: Throughout length of study
description: 3. For evaluation of disease-specific differences in relative quantity and function of peripheral blood and tissue immune cells most comparisons will be made using 2-tailed Student t tests with statistical significance set at a p less than or equal to 0.05.
arm group label: IBD
description: -Patients with IBD without a diagnosed PIDD.-First- or second-degree relatives of patients with a PIDD of interest who do not have a PIDD themselves, but have diagnosed or suspected IBD.
arm group label: Non-PIDD/non-IBD (healthy volunteers)
description: healthy volunteers
arm group label: PIDD
description: CGD cohort; IPEX syndrome cohort; CTLA4 haploinsufficiency cohort; LRBA deficiency and hypomorphic RAG deficiency cohorts
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christa S Zerbe, M.D.
role: Principal Investigator
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-I-0163.html
description: NIH Clinical Center Detailed Web Page
citation: Agarwal S, Mayer L. Gastrointestinal manifestations in primary immune disorders. Inflamm Bowel Dis. 2010 Apr;16(4):703-11. doi: 10.1002/ibd.21040.
PMID: 19637385
citation: Marciano BE, Rosenzweig SD, Kleiner DE, Anderson VL, Darnell DN, Anaya-O'Brien S, Hilligoss DM, Malech HL, Gallin JI, Holland SM. Gastrointestinal involvement in chronic granulomatous disease. Pediatrics. 2004 Aug;114(2):462-8. doi: 10.1542/peds.114.2.462.
PMID: 15286231
citation: Uhlig HH. Monogenic diseases associated with intestinal inflammation: implications for the understanding of inflammatory bowel disease. Gut. 2013 Dec;62(12):1795-805. doi: 10.1136/gutjnl-2012-303956.
PMID: 24203055
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
mesh term: Granulomatous Disease, Chronic
mesh term: Inflammation
sharing ipd: Yes
ipd description: .The following will be shared:@@@@@@ (Summation)De-identified data in an NIH-funded or approved public repository.@@@@@@ (Summation)Identified data in the Biomedical Translational Research Information System (BTRIS).@@@@@@.De-identified or identified data with approved NIH-based and/or outside collaborators under appropriate agreements.
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be shared before publication, at publication or shortly after publication.
ipd access criteria: Data will be shared through:@@@@@@ (Summation)An NIH-funded or approved public repository: National Center for Biotechnology Information Sequence Read Archive (NCBI SRA) Database.@@@@@@ (Summation)BTRIS.@@@@@@ (Summation)Approved outside collaborators under appropriate individual agreements.@@@@@@ (Summation)Publication and/or public presentations.@@@@@@The PI will review and approve/disapprove requests for IDP.