<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/NCT03300830</url>
  </required_header>
  <id_info>
    <org_study_id>170174</org_study_id>
    <secondary_id>17-C-0174</secondary_id>
    <nct_id>NCT03300830</nct_id>
  </id_info>
  <brief_title>Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease</brief_title>
  <official_title>Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease</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>
  <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;
      A person s genome is the collection of all their genes. A gene instructs individual cells to&#xD;
      make proteins. Proteins are involved in all of our body s chemical processes. Genome&#xD;
      sequencing allows researchers to find variations in genes. Some of these are normal and are&#xD;
      not known to cause disease. Some variants are known to cause or affect diseases like cancer.&#xD;
      Researchers want to study genetic variants in people with cancer who also have an immunologic&#xD;
      disease like HIV.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To study the biology of cancer in order to improve ways to prevent, detect, and treat it.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Adults at least 18 years old with certain cancers and/or immunodeficiencies&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with medical history, physical exam, and lab tests.&#xD;
&#xD;
      Participants will give samples of one or more tissue type.&#xD;
&#xD;
      They may give blood or urine samples.&#xD;
&#xD;
      Researchers may get samples of tissue when participants have surgery or when the participants&#xD;
      are on other protocols in the NCI.&#xD;
&#xD;
      Participants may have a procedure to have tissue samples removed.&#xD;
&#xD;
      Researchers may collect data from participant medical records.&#xD;
&#xD;
      Researchers will compare the genes in a participant s cancer tissue to their normal tissue.&#xD;
      They may use the tissue cells to grow new cells in a lab.&#xD;
&#xD;
      Participants may be contacted about the results.&#xD;
&#xD;
      The samples will be stored for future research. No personal data will be kept with them.&#xD;
&#xD;
      ...&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
        -  The availability of high quality, clinically annotated patient samples is crucial for&#xD;
           the study of biologic factors that influence the natural history of viral related&#xD;
           malignancies, malignancies occurring in the setting of HIV, and Castleman disease&#xD;
&#xD;
        -  Comprehensive genomic sequence of viral-associated malignancies, malignancies occurring&#xD;
           in the setting of HIV, tumors hypothesized to be caused by endogenous retroviruses, and&#xD;
           Castleman disease may identify diagnostic or prognostic disease signatures, and&#xD;
           recurrent driver alterations that interact with viral factors, and may identify targets&#xD;
           for new therapies&#xD;
&#xD;
        -  Comparison of transcriptomes and genomes between cancers or Castleman disease from HIV+&#xD;
           and HIV- individuals might identify novel non-human sequences that could potentially&#xD;
           suggest the presence of transcripts from hitherto undiscovered oncogenic viral agents&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      -The primary objective of this protocol is to support molecular investigation of viral&#xD;
      associated malignancies, malignancies occurring in the setting of HIV or other&#xD;
      immunodeficiencies, and Castleman disease, by accrual of high quality, clinically annotated&#xD;
      tissue from such patients as well as patients with tumors that may serve as appropriate&#xD;
      controls.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
        -  Age &gt;18 years&#xD;
&#xD;
        -  HIV or other acquired immunodeficiency and cancer or&#xD;
&#xD;
        -  Viral-associated cancer or&#xD;
&#xD;
        -  HIV-negative with cancer that commonly occurs in people with HIV or&#xD;
&#xD;
        -  Kaposi sarcoma herpes virus (KSHV)-associated malignancy or related diseases, such as&#xD;
           Multicentric Castleman Disease or&#xD;
&#xD;
        -  Idiopathic Castleman disease or&#xD;
&#xD;
        -  Tumors that are hypothesized to be caused by endogenous retroviruses&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Samples will be processed using project specific collection and processing protocols.&#xD;
&#xD;
        -  Collection of non-tumor specimens will generally be performed to obtain germ-line&#xD;
           genetic material. The results between tumor and normal DNA will be analyzed to identify&#xD;
           the somatic changes present in the cancer tissues.&#xD;
&#xD;
        -  Alterations to be evaluated may include: detection of chromosomal changes, such as, but&#xD;
           not limited to, amplification, deletions, loss of heterozygosity, translocations, etc.;&#xD;
           as well as expression profiling and detection of transcripts resulting from&#xD;
           translocations and mutations, including single nucleotide variants, insertions,&#xD;
           deletions, etc.&#xD;
&#xD;
        -  Multiple forms of project specific analyses may be performed, including evaluation of&#xD;
           polymorphisms, mutations, gene expression, , circulatory and tissue-based biomarkers,&#xD;
           whole exome sequencing, and clinical pathologic correlation based on project specific&#xD;
           statistical and bioinformatics plans.&#xD;
&#xD;
        -  Alterations may also be analyzed within the context of biological pathways and systems&#xD;
           biology being evaluated in a given project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 20, 2017</start_date>
  <completion_date type="Anticipated">June 25, 2037</completion_date>
  <primary_completion_date type="Anticipated">June 7, 2037</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>Tissue collection</measure>
    <time_frame>Time of collection</time_frame>
    <description>Molecular data from viral associated malignancies, malignancies occurring in the setting of HIV or other immunodeficiencies, and Castleman disease</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">230</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <condition>Castleman's Disease</condition>
  <condition>Kaposi's Sarcoma</condition>
  <condition>Viral-Associated Cancer</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <description>Viral-assoc. cancer; HIV-neg pts with cancer that occurs in HIV pos; KSHV-assoc. cancer or related diseases e.g. multicentric Castleman disease; retrovirus-induced cancer; Idiopathic Castleman disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be patients referred by HIV providers and those who provide&#xD;
        primary care to the African immigrant community.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        Patients with one or more of the following:&#xD;
&#xD;
          -  HIV or other acquired immunodeficiency and cancer&#xD;
&#xD;
          -  Viral-associated cancer or cancer hypothesized to be caused by a virus&#xD;
&#xD;
          -  HIV-negative patients with cancer that commonly occurs in people with HIV&#xD;
&#xD;
          -  KSHV-associated malignancy or related diseases, such as Multicentric Castleman Disease&#xD;
&#xD;
          -  A malignancy hypothesized to be caused by an endogenous retrovirus&#xD;
&#xD;
          -  Idiopathic Castleman disease&#xD;
&#xD;
        Cancer diagnoses will be confirmed by the NCI Laboratory of Pathology. A biopsy will be&#xD;
        collected if sufficient archival tissue is not available.&#xD;
&#xD;
          -  Age &gt;18 years.&#xD;
&#xD;
          -  ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to&#xD;
             .60%) if biopsy to be performed is solely for the purposes of this protocol. Any ECOG&#xD;
             performance status will be allowed if biopsy required for patient care or another NIH&#xD;
             protocol that allows lower performance status or if enrollment on this protocol is&#xD;
             only for the purposes of studying tissue that has already been collected.&#xD;
&#xD;
          -  Patients must have signed or be willing to sign an IRB-approved informed consent&#xD;
             document that permits the use of the tumor and other samples for genomic-based&#xD;
             molecular characterization projects. Telephone consent for use of archival tissue or&#xD;
             tissue collected on another protocol or standard patient care will be permitted.&#xD;
&#xD;
          -  Co-enrollment on other HAMB, NCI, or NIH protocols is allowed&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Inability to provide informed consent.&#xD;
&#xD;
          -  Pregnancy: Pregnant women will not be allowed to participate in this study because&#xD;
             there is not a potential benefit.&#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>Robert Yarchoan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Irene Ekwede, R.N.</last_name>
    <phone>(240) 760-6126</phone>
    <email>ekwedeib@mail.nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robert Yarchoan, M.D.</last_name>
    <phone>(240) 760-6075</phone>
    <email>robert.yarchoan@nih.gov</email>
  </overall_contact_backup>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>For more information at the NIH Clinical Center contact National Cancer Institute Referral Office</last_name>
      <phone>888-624-1937</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-C-0174.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>September 6, 2023</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 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 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunodeficiency</keyword>
  <keyword>Viral-Associated Cancer</keyword>
  <keyword>Kaposi Sarcoma Herpes Virus</keyword>
  <keyword>Idiopathic Castleman Disease</keyword>
  <keyword>Endogenous Retroviruses</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Sarcoma, Kaposi</mesh_term>
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Castleman Disease</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
    <mesh_term>Immune System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.</ipd_time_frame>
    <ipd_access_criteria>Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians</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/NCT03300830
org study id: 170174
secondary id: 17-C-0174
nct id: NCT03300830
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      A person s genome is the collection of all their genes. A gene instructs individual cells to
      make proteins. Proteins are involved in all of our body s chemical processes. Genome
      sequencing allows researchers to find variations in genes. Some of these are normal and are
      not known to cause disease. Some variants are known to cause or affect diseases like cancer.
      Researchers want to study genetic variants in people with cancer who also have an immunologic
      disease like HIV.

      Objective:

      To study the biology of cancer in order to improve ways to prevent, detect, and treat it.

      Eligibility:

      Adults at least 18 years old with certain cancers and/or immunodeficiencies

      Design:

      Participants will be screened with medical history, physical exam, and lab tests.

      Participants will give samples of one or more tissue type.

      They may give blood or urine samples.

      Researchers may get samples of tissue when participants have surgery or when the participants
      are on other protocols in the NCI.

      Participants may have a procedure to have tissue samples removed.

      Researchers may collect data from participant medical records.

      Researchers will compare the genes in a participant s cancer tissue to their normal tissue.
      They may use the tissue cells to grow new cells in a lab.

      Participants may be contacted about the results.

      The samples will be stored for future research. No personal data will be kept with them.

      ...
Background:

        -  The availability of high quality, clinically annotated patient samples is crucial for
           the study of biologic factors that influence the natural history of viral related
           malignancies, malignancies occurring in the setting of HIV, and Castleman disease

        -  Comprehensive genomic sequence of viral-associated malignancies, malignancies occurring
           in the setting of HIV, tumors hypothesized to be caused by endogenous retroviruses, and
           Castleman disease may identify diagnostic or prognostic disease signatures, and
           recurrent driver alterations that interact with viral factors, and may identify targets
           for new therapies

        -  Comparison of transcriptomes and genomes between cancers or Castleman disease from HIV+
           and HIV- individuals might identify novel non-human sequences that could potentially
           suggest the presence of transcripts from hitherto undiscovered oncogenic viral agents

      Objective:

      -The primary objective of this protocol is to support molecular investigation of viral
      associated malignancies, malignancies occurring in the setting of HIV or other
      immunodeficiencies, and Castleman disease, by accrual of high quality, clinically annotated
      tissue from such patients as well as patients with tumors that may serve as appropriate
      controls.

      Eligibility:

        -  Age >18 years

        -  HIV or other acquired immunodeficiency and cancer or

        -  Viral-associated cancer or

        -  HIV-negative with cancer that commonly occurs in people with HIV or

        -  Kaposi sarcoma herpes virus (KSHV)-associated malignancy or related diseases, such as
           Multicentric Castleman Disease or

        -  Idiopathic Castleman disease or

        -  Tumors that are hypothesized to be caused by endogenous retroviruses

      Design:

        -  Samples will be processed using project specific collection and processing protocols.

        -  Collection of non-tumor specimens will generally be performed to obtain germ-line
           genetic material. The results between tumor and normal DNA will be analyzed to identify
           the somatic changes present in the cancer tissues.

        -  Alterations to be evaluated may include: detection of chromosomal changes, such as, but
           not limited to, amplification, deletions, loss of heterozygosity, translocations, etc.;
           as well as expression profiling and detection of transcripts resulting from
           translocations and mutations, including single nucleotide variants, insertions,
           deletions, etc.

        -  Multiple forms of project specific analyses may be performed, including evaluation of
           polymorphisms, mutations, gene expression, , circulatory and tissue-based biomarkers,
           whole exome sequencing, and clinical pathologic correlation based on project specific
           statistical and bioinformatics plans.

        -  Alterations may also be analyzed within the context of biological pathways and systems
           biology being evaluated in a given project.
observational model: Cohort
time perspective: Prospective
measure: Tissue collection
time frame: Time of collection
description: Molecular data from viral associated malignancies, malignancies occurring in the setting of HIV or other immunodeficiencies, and Castleman disease
arm group label: group 1
description: Viral-assoc. cancer; HIV-neg pts with cancer that occurs in HIV pos; KSHV-assoc. cancer or related diseases e.g. multicentric Castleman disease; retrovirus-induced cancer; Idiopathic Castleman disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Yarchoan, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
last name: Irene Ekwede, R.N.
phone: (240) 760-6126
email: ekwedeib@mail.nih.gov
last name: Robert Yarchoan, M.D.
phone: (240) 760-6075
email: robert.yarchoan@nih.gov
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-C-0174.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Sarcoma, Kaposi
mesh term: Sarcoma
mesh term: Castleman Disease
mesh term: Immunologic Deficiency Syndromes
mesh term: Immune System Diseases
sharing ipd: Yes
ipd description: .All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
ipd access criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians