<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/NCT03762733</url>
  </required_header>
  <id_info>
    <org_study_id>190025</org_study_id>
    <secondary_id>19-C-0025</secondary_id>
    <nct_id>NCT03762733</nct_id>
  </id_info>
  <brief_title>Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies</brief_title>
  <official_title>Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies</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 blood, tissue, and other samples contain DNA. Cancer is a disease of cells that&#xD;
      are not working properly. It is caused by changes in DNA that build up. Researchers want to&#xD;
      do future studies on DNA changes This may help them learn how to guide treatment for cancer.&#xD;
      They need biological samples like tumors, blood, and urine for these studies.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To create a place to collect and store biological samples from people with gynecologic&#xD;
      malignancies like breast cancer. Samples from certain relatives of theirs will be collected&#xD;
      too.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Adults ages 18 and older who are being seen at NIH for breast cancer or other gynecologic&#xD;
      malignancy&#xD;
&#xD;
      Their biological relatives of the same age&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will answer questions about their family history.&#xD;
&#xD;
      Participants will have a physical exam and medical history. This will include questions about&#xD;
      age, ethnicity, and disease history. They will also answer questions about their medical&#xD;
      treatments and responses.&#xD;
&#xD;
      Participants will give blood and urine samples.&#xD;
&#xD;
      Participants may give a tumor tissue sample. This will not be taken specifically for this&#xD;
      study. It will be from a previous procedure or one that is already planned.&#xD;
&#xD;
      Other samples may be taken only if a procedure is required for treatment. These include bone&#xD;
      marrow, cerebrospinal fluid, and other fluids.&#xD;
&#xD;
      A group of doctors and other professionals will oversee the sample storage place. The group&#xD;
      will review all requests to be sure the use of the specimens is valid.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Increased understanding of the genomic variations of cancer through laboratory evaluations&#xD;
      can result in breakthroughs in treatment and improved patient outcomes.&#xD;
&#xD;
      Exceptional responders on clinical trials may have mutational characteristics that are unique&#xD;
      and unknown, necessitating identification.&#xD;
&#xD;
      Current drug development strategies employ precision oncology. This approach identifies&#xD;
      molecular targets, with therapies being either chosen or developed to interact with the&#xD;
      specific target.&#xD;
&#xD;
      The collection and banking of a variety of tissue samples for future translational studies&#xD;
      would support research and advance the mission of the NIH.&#xD;
&#xD;
      Pleural effusions, ascites as well as other tissues, such as blood, CSF, tumor, bone marrow,&#xD;
      and urine, provide a unique opportunity to conduct a variety of translational research,&#xD;
      addressing many clinical questions.&#xD;
&#xD;
      The establishment of a tissue repository would enhance the mission of the NCI, in helping to&#xD;
      advance research supporting precision oncology.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      To establish a tissue repository for the collection and banking of tissue samples from&#xD;
      patients with breast and/or other gynecologic malignancies, as well as patients consenting&#xD;
      1st -3rd degree biological relatives, seen at the NIH for support of future translational&#xD;
      research conducted at the NIH.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Personal diagnosis of breast or other gynecologic malignancy, or be a 1st-3rd degree&#xD;
      biological relative of a patient with cancer, currently or previously on a NIH clinical&#xD;
      trial.&#xD;
&#xD;
      All subjects (index patient with cancer and their 1st-3rd degree biological relatives) must&#xD;
      sign consent and enroll onto this study, in order to donate tissue for biobanking on this&#xD;
      protocol.&#xD;
&#xD;
      Adults, &gt;= age 18, willing to provide tissue for biobanking&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Samples include, but are not limited to, tumor (e.g., tissue, outside paraffin blocks or&#xD;
      slides), blood, serum, plasma, and urine; to be collected after subjects have met eligibility&#xD;
      and signed consent. Clinically-indicated samples (e.g., bone marrow, cerebrospinal fluid&#xD;
      (CSF), malignant ascites, and effusions) collected under treatment protocols may be&#xD;
      transferred to this biorepository protocol for research We will also obtain samples (mainly&#xD;
      blood) from volunteer, consenting 1st-3rd degree biological relatives of patients with&#xD;
      histologically confirmed cancer, to be paired with their family member.&#xD;
&#xD;
      Tissue will be accessed by study investigators. Additional CCR investigators who wish to use&#xD;
      tissue from this repository must first provide a written Letter of Intent, (LOI), to be&#xD;
      reviewed by an investigator appointed ad hoc committee for approval.&#xD;
&#xD;
      Assays used for sample processing, establishment of cell lines, patient derived xenograft&#xD;
      models, and storage are described in detail within this protocol. Also, some assays for&#xD;
      future translational research are either listed or described herein. Further detailed&#xD;
      description of experimental designs, along with statistical analysis, will be provided within&#xD;
      future investigator-initiated sample use addendums to this protocol, or new IRB approved&#xD;
      protocols, developed in order to study samples from this biorepository.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">January 4, 2022</start_date>
  <completion_date type="Anticipated">December 29, 2028</completion_date>
  <primary_completion_date type="Anticipated">December 29, 2028</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>Establishment of a tissue repository for the collection and banking of tissue samples</measure>
    <time_frame>at study completion</time_frame>
    <description>A tissue repository</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Uterine Cancer</condition>
  <arm_group>
    <arm_group_label>Patient Relatives</arm_group_label>
    <description>Biological relatives (1st-3rd degree) of participants with histologically confirmed malignancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Participants with histologically confirmed malignancy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are being seen in follow up, consultation, or presenting for enrollment on a&#xD;
        clinical trial at the NIH Clinical Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Adult subject (age 18 and older) co-enrolled on a trial, or otherwise undergoing&#xD;
             consultation, screening, or follow up on existing protocols conducted at the NIH&#xD;
             Clinical Center, who are evaluated in the Women s Malignancies Branch Clinic.&#xD;
&#xD;
          -  Participant or biological relative of a participant, as follows:&#xD;
&#xD;
          -  Participant with a histologically confirmed breast cancer or other gynecologic&#xD;
             malignancy; histopathology of the biopsy tissue must be&#xD;
&#xD;
        confirmed by the NCI Laboratory of Pathology, prior to banking of the tissue on this&#xD;
        protocol.&#xD;
&#xD;
          -  Biological relative (1st 3rd degree) of a participant who meets the eligibility of&#xD;
             histologically confirmed malignancy per above&#xD;
&#xD;
        criterion.&#xD;
&#xD;
          -  Subject willingness and ability to provide informed consent.&#xD;
&#xD;
          -  Subject willingness to provide tissue samples for banking.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        - Pregnant individuals are not eligible to take part; pregnancy will be assessed using&#xD;
        clinical criteria (medical history and physical exam).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jung-Min Lee, 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?A_2019-C-0025.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>July 21, 2023</verification_date>
  <study_first_submitted>December 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Biobanking</keyword>
  <keyword>Tissue Repository</keyword>
  <keyword>Genetic Analysis</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Uterine Neoplasms</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/NCT03762733
org study id: 190025
secondary id: 19-C-0025
nct id: NCT03762733
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      A person s blood, tissue, and other samples contain DNA. Cancer is a disease of cells that
      are not working properly. It is caused by changes in DNA that build up. Researchers want to
      do future studies on DNA changes This may help them learn how to guide treatment for cancer.
      They need biological samples like tumors, blood, and urine for these studies.

      Objective:

      To create a place to collect and store biological samples from people with gynecologic
      malignancies like breast cancer. Samples from certain relatives of theirs will be collected
      too.

      Eligibility:

      Adults ages 18 and older who are being seen at NIH for breast cancer or other gynecologic
      malignancy

      Their biological relatives of the same age

      Design:

      Participants will answer questions about their family history.

      Participants will have a physical exam and medical history. This will include questions about
      age, ethnicity, and disease history. They will also answer questions about their medical
      treatments and responses.

      Participants will give blood and urine samples.

      Participants may give a tumor tissue sample. This will not be taken specifically for this
      study. It will be from a previous procedure or one that is already planned.

      Other samples may be taken only if a procedure is required for treatment. These include bone
      marrow, cerebrospinal fluid, and other fluids.

      A group of doctors and other professionals will oversee the sample storage place. The group
      will review all requests to be sure the use of the specimens is valid.
Background:

      Increased understanding of the genomic variations of cancer through laboratory evaluations
      can result in breakthroughs in treatment and improved patient outcomes.

      Exceptional responders on clinical trials may have mutational characteristics that are unique
      and unknown, necessitating identification.

      Current drug development strategies employ precision oncology. This approach identifies
      molecular targets, with therapies being either chosen or developed to interact with the
      specific target.

      The collection and banking of a variety of tissue samples for future translational studies
      would support research and advance the mission of the NIH.

      Pleural effusions, ascites as well as other tissues, such as blood, CSF, tumor, bone marrow,
      and urine, provide a unique opportunity to conduct a variety of translational research,
      addressing many clinical questions.

      The establishment of a tissue repository would enhance the mission of the NCI, in helping to
      advance research supporting precision oncology.

      Primary Objective:

      To establish a tissue repository for the collection and banking of tissue samples from
      patients with breast and/or other gynecologic malignancies, as well as patients consenting
      1st -3rd degree biological relatives, seen at the NIH for support of future translational
      research conducted at the NIH.

      Eligibility:

      Personal diagnosis of breast or other gynecologic malignancy, or be a 1st-3rd degree
      biological relative of a patient with cancer, currently or previously on a NIH clinical
      trial.

      All subjects (index patient with cancer and their 1st-3rd degree biological relatives) must
      sign consent and enroll onto this study, in order to donate tissue for biobanking on this
      protocol.

      Adults, >= age 18, willing to provide tissue for biobanking

      Design:

      Samples include, but are not limited to, tumor (e.g., tissue, outside paraffin blocks or
      slides), blood, serum, plasma, and urine; to be collected after subjects have met eligibility
      and signed consent. Clinically-indicated samples (e.g., bone marrow, cerebrospinal fluid
      (CSF), malignant ascites, and effusions) collected under treatment protocols may be
      transferred to this biorepository protocol for research We will also obtain samples (mainly
      blood) from volunteer, consenting 1st-3rd degree biological relatives of patients with
      histologically confirmed cancer, to be paired with their family member.

      Tissue will be accessed by study investigators. Additional CCR investigators who wish to use
      tissue from this repository must first provide a written Letter of Intent, (LOI), to be
      reviewed by an investigator appointed ad hoc committee for approval.

      Assays used for sample processing, establishment of cell lines, patient derived xenograft
      models, and storage are described in detail within this protocol. Also, some assays for
      future translational research are either listed or described herein. Further detailed
      description of experimental designs, along with statistical analysis, will be provided within
      future investigator-initiated sample use addendums to this protocol, or new IRB approved
      protocols, developed in order to study samples from this biorepository.
observational model: Cohort
time perspective: Prospective
measure: Establishment of a tissue repository for the collection and banking of tissue samples
time frame: at study completion
description: A tissue repository
arm group label: Patient Relatives
description: Biological relatives (1st-3rd degree) of participants with histologically confirmed malignancy
arm group label: Patients
description: Participants with histologically confirmed malignancy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jung-Min Lee, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2019-C-0025.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Uterine Neoplasms
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.