<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/NCT03027401</url>
  </required_header>
  <id_info>
    <org_study_id>170040</org_study_id>
    <secondary_id>17-C-0040</secondary_id>
    <nct_id>NCT03027401</nct_id>
  </id_info>
  <brief_title>Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics</brief_title>
  <official_title>Clinical Sequencing of Cancer and Tissue Repository: ClinOmics</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;
      Saliva, blood, tissue, and cancer contain DNA. DNA makes the &quot;instruction book&quot; for the cells&#xD;
      in the body. Cancer is caused by changes in DNA that affect cell function. Researchers want&#xD;
      to test DNA of people with tumors. They want to look for genetic changes in tumors that could&#xD;
      be targets for treatment. Because DNA can change as cancer changes, more testing may be done&#xD;
      at different times.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To find the DNA changes in cancer that may help guide treatment. To collect samples and data&#xD;
      to be used in future studies.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People any age with cancer or a pre-cancerous tumor&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be screened with a medical history, physical exam, and blood tests.&#xD;
           Participants will give a sample of their tumor. This is usually from a previous&#xD;
           procedure. Participants will give a saliva or blood sample. They cannot eat, drink,&#xD;
           smoke, or chew gum for 30 minutes before giving saliva. They will spit about 1 teaspoon&#xD;
           of saliva into a tube.&#xD;
&#xD;
        -  Some participants may have a punch biopsy instead. A small instrument will take a small&#xD;
           piece of skin.&#xD;
&#xD;
        -  Researchers will collect data from participants medical records.&#xD;
&#xD;
        -  Participants will answer questions about their family health history. They will also&#xD;
           answer questions about their views on the study, including possible unexpected results.&#xD;
&#xD;
        -  Extra blood or tissue samples may be taken at other times during the participants'&#xD;
           treatment. All samples will be saved in secure ClinOmics freezers to be used in future&#xD;
           studies.&#xD;
&#xD;
        -  Participants will be told by their doctors if any test results affect their health or&#xD;
           their cancer treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
        -  Laboratory-based investigations have contributed to an improved understanding of the&#xD;
           biology of cancer and to the development of new therapies for malignancies.&#xD;
&#xD;
        -  Omics investigation may identify novel drivers in the germline or tumor for high risk,&#xD;
           relapsed, refractory or rare cancers.&#xD;
&#xD;
        -  Omics investigation may identify germline or somatic alterations that are medically&#xD;
           actionable and or can enable precision therapy.&#xD;
&#xD;
      Objectives - Primary Objective:&#xD;
&#xD;
      -Identify incidental and secondary findings in germline DNA and actionable somatic mutations&#xD;
      for reporting clinical results from a CLIA-certified lab into CRIS medical records.&#xD;
&#xD;
      Eligibility - Adult or Pediatric patients of any age with one of the following:&#xD;
&#xD;
        -  Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected cancer&#xD;
           susceptibility familial syndromes, regardless of patient age; OR&#xD;
&#xD;
        -  Individuals without history of malignancy who are undergoing surgery; OR&#xD;
&#xD;
        -  Individuals without a history of cancer but evidence of an inherited cancer syndrome&#xD;
           based on family history and/or other manifestations of a pre-cancerous syndrome (e.g.&#xD;
           polyposis, plexiform neurofibromas, myelodysplastic disease); OR&#xD;
&#xD;
        -  Patient enrolled in an approved companion protocol.&#xD;
&#xD;
        -  Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues)&#xD;
           that has been previously collected under CLIA and maintained in a CLIA lab which is&#xD;
           available for CLIA analysis.&#xD;
&#xD;
        -  Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues)&#xD;
           that has been previously collected and is available for research analysis.&#xD;
&#xD;
        -  Biospecimens can be collected with minimal additional risk to the subject during&#xD;
           sampling or procedures required for routine patient care.&#xD;
&#xD;
        -  Individual may be undergoing treatment for malignancy, premalignant condition or&#xD;
           receiving other care associated with an inherited cancer syndrome.&#xD;
&#xD;
        -  Patients may be referred to the Principal Investigator from outside institutions.&#xD;
&#xD;
        -  Ability of subject or Legally Authorized Representative (LAR) to understand and the&#xD;
           willingness to sign a written informed consent OR&#xD;
&#xD;
        -  IRB waiver of the requirement for informed consent for specific types of tissue.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  This study will allow for the collection of specimens for CLIA reporting of germline and&#xD;
           somatic mutations. The study will also collect specimens for a Tissue Repository, and&#xD;
           for other investigations as outlined below.&#xD;
&#xD;
        -  CLIA testing activities will include&#xD;
&#xD;
             -  DNA extracted from a section of tumor, malignant tissue, blood, or bone marrow&#xD;
                samples for somatic mutation sequence analysis&#xD;
&#xD;
             -  Germline DNA extracted from lymphocytes, saliva, skin, or any normal uninvolved&#xD;
                tissues for sequence analysis to identify somatic alterations in the cancer and for&#xD;
                the reporting of incidental findings of established clinical validity and utility.&#xD;
&#xD;
        -  Research activities may include:&#xD;
&#xD;
             -  DNA, RNA and protein Omics analyses from extracted normal and/or tumor tissues; the&#xD;
                remainder of the tumor tissue will be stored.&#xD;
&#xD;
             -  Germline DNA and RNA analyses from extracted lymphocytes or other normal uninvolved&#xD;
                tissue.&#xD;
&#xD;
             -  T (TCR) or B Cell Receptor sequencing from blood, tumor, or malignant tissue.&#xD;
&#xD;
             -  Establishing Patient-Derived Models such as patient-derived xenografts (PDXs),&#xD;
                early-passage in vitro tumor cultures, and organoid cultures, conditionally&#xD;
                reprogrammed cells (CRC) lines, explant and cell lines from tumor or normal samples&#xD;
                by the NCI Patient-Derived Models Repository (PDMR) at Frederick National&#xD;
                Laboratory for Cancer Research or by the OncoGenomics laboratory.&#xD;
&#xD;
             -  Cryopreservation of viable normal (e.g. PBMC) or malignant tissues.&#xD;
&#xD;
             -  Establishment of EBV transformed cell lines from blood for medical research either&#xD;
                by Coriell Institute or by investigators on this protocol.&#xD;
&#xD;
             -  Omics (Genomics, Proteomic, Epigenetics, Metabolomics) studies will be performed.&#xD;
&#xD;
        -  Expected accrual 50-500 patients per year. Total protocol accrual goal 5,000 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    closed by PI and FDA&#xD;
  </why_stopped>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Actual">October 5, 2020</completion_date>
  <primary_completion_date type="Actual">October 5, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify incidental and secondary findings in germline DNA and actionable somatic mutations for reporting clinical results from a CLIA-certified lab into CRIS medical records.</measure>
    <time_frame>ongoing</time_frame>
    <description>Sample analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Molecular, genomic, epigenetic, transcriptomic, proteomic, metabolomics and other &quot;omics&quot; profiling on tumors, malignancies and normal tissues</measure>
    <time_frame>ongoing</time_frame>
    <description>Sample analysis for identification of biomarkers, drivers and medically actionable targets for clinical management.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Create a tissue repository</measure>
    <time_frame>ongoing</time_frame>
    <description>Repository for analysis of samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extraction and storage of circulating tumor DNA</measure>
    <time_frame>ongoing</time_frame>
    <description>Storage of samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Establishing Patient-derived models</measure>
    <time_frame>ongoing</time_frame>
    <description>Analysis of samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cryopreservation of viable tumor tissue for future study</measure>
    <time_frame>ongoing</time_frame>
    <description>Sample storage for future analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Establishment of EBV transformed cell lines for research</measure>
    <time_frame>ongoing</time_frame>
    <description>Analysis of germline samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creation of an OncoGenomics oversight committee</measure>
    <time_frame>ongoing</time_frame>
    <description>Oversight and development of new treatment approaches.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of effects of the informed consent process</measure>
    <time_frame>ongoing</time_frame>
    <description>Survey data collection and analysis.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Neoplasms</condition>
  <condition>Adenomatous Polyposis Coli</condition>
  <condition>Neurofibroma, Plexiform</condition>
  <condition>Myelodysplastic Syndromes</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Adult/pediatric with suspected or confirmed malignancy, family history of malignancy, undergoing surgery with no malignancy; tissues collected previously under CLIA or for research.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Samples for the population cohort will be selected from patients that are co-enrolled on&#xD;
        other NIH protocols (both inpatient and outpatient) as well as community referrals from&#xD;
        outside NIH.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        Adult or Pediatric patients with one of the following:&#xD;
&#xD;
          -  Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected cancer&#xD;
             susceptibility familial syndromes, regardless of patient age; OR&#xD;
&#xD;
          -  Individuals without history of malignancy who are undergoing surgery; OR&#xD;
&#xD;
          -  Individuals without a history of cancer but evidence of an inherited cancer syndrome&#xD;
             based on family history and/or other manifestations of the syndrome (i.e. polyposis,&#xD;
             plexiform neurofibromas, myelodysplastic syndrome); OR&#xD;
&#xD;
          -  Tissue (including tumor, normal, blood, serum, plasma, or other tissues) that has been&#xD;
             previously collected under CLIA and maintained in a CLIA lab which is available for&#xD;
             CLIA analysis.&#xD;
&#xD;
          -  Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues)&#xD;
             that has been previously collected and is available for research analysis.&#xD;
&#xD;
          -  Biospecimens can be collected with minimal additional risk to the subject during&#xD;
             sampling or procedures required for routine patient care.&#xD;
&#xD;
          -  Individual may be undergoing treatment for malignancy, premalignant condition or&#xD;
             receiving other care associated with an inherited cancer syndrome.&#xD;
&#xD;
          -  Ability of subject or Legally Authorized Representative (LAR) to understand and the&#xD;
             willingness to sign a written informed consent; OR&#xD;
&#xD;
          -  IRB waiver of the requirement for informed consent for specific types of tissue.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        -None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javed Khan, 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_2017-C-0040.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Green RC, Berg JS, Grody WW, Kalia SS, Korf BR, Martin CL, McGuire AL, Nussbaum RL, O'Daniel JM, Ormond KE, Rehm HL, Watson MS, Williams MS, Biesecker LG; American College of Medical Genetics and Genomics. ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med. 2013 Jul;15(7):565-74. doi: 10.1038/gim.2013.73. Epub 2013 Jun 20. Erratum In: Genet Med. 2017 May;19(5):606.</citation>
    <PMID>23788249</PMID>
  </reference>
  <reference>
    <citation>Weiner C. Anticipate and communicate: Ethical management of incidental and secondary findings in the clinical, research, and direct-to-consumer contexts (December 2013 report of the Presidential Commission for the Study of Bioethical Issues). Am J Epidemiol. 2014 Sep 15;180(6):562-4. doi: 10.1093/aje/kwu217. Epub 2014 Aug 22.</citation>
    <PMID>25150271</PMID>
  </reference>
  <reference>
    <citation>Appelbaum PS, Waldman CR, Fyer A, Klitzman R, Parens E, Martinez J, Price WN 2nd, Chung WK. Informed consent for return of incidental findings in genomic research. Genet Med. 2014 May;16(5):367-73. doi: 10.1038/gim.2013.145. Epub 2013 Oct 24.</citation>
    <PMID>24158054</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>October 7, 2020</last_update_submitted>
  <last_update_submitted_qc>October 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Genetic Testing</keyword>
  <keyword>Tumor Profiling</keyword>
  <keyword>Biorepository</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurofibroma</mesh_term>
    <mesh_term>Adenomatous Polyposis Coli</mesh_term>
    <mesh_term>Neurofibroma, Plexiform</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</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/NCT03027401
org study id: 170040
secondary id: 17-C-0040
nct id: NCT03027401
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      Saliva, blood, tissue, and cancer contain DNA. DNA makes the "instruction book" for the cells
      in the body. Cancer is caused by changes in DNA that affect cell function. Researchers want
      to test DNA of people with tumors. They want to look for genetic changes in tumors that could
      be targets for treatment. Because DNA can change as cancer changes, more testing may be done
      at different times.

      Objectives:

      To find the DNA changes in cancer that may help guide treatment. To collect samples and data
      to be used in future studies.

      Eligibility:

      People any age with cancer or a pre-cancerous tumor

      Design:

        -  Participants will be screened with a medical history, physical exam, and blood tests.
           Participants will give a sample of their tumor. This is usually from a previous
           procedure. Participants will give a saliva or blood sample. They cannot eat, drink,
           smoke, or chew gum for 30 minutes before giving saliva. They will spit about 1 teaspoon
           of saliva into a tube.

        -  Some participants may have a punch biopsy instead. A small instrument will take a small
           piece of skin.

        -  Researchers will collect data from participants medical records.

        -  Participants will answer questions about their family health history. They will also
           answer questions about their views on the study, including possible unexpected results.

        -  Extra blood or tissue samples may be taken at other times during the participants'
           treatment. All samples will be saved in secure ClinOmics freezers to be used in future
           studies.

        -  Participants will be told by their doctors if any test results affect their health or
           their cancer treatment.
Background:

        -  Laboratory-based investigations have contributed to an improved understanding of the
           biology of cancer and to the development of new therapies for malignancies.

        -  Omics investigation may identify novel drivers in the germline or tumor for high risk,
           relapsed, refractory or rare cancers.

        -  Omics investigation may identify germline or somatic alterations that are medically
           actionable and or can enable precision therapy.

      Objectives - Primary Objective:

      -Identify incidental and secondary findings in germline DNA and actionable somatic mutations
      for reporting clinical results from a CLIA-certified lab into CRIS medical records.

      Eligibility - Adult or Pediatric patients of any age with one of the following:

        -  Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected cancer
           susceptibility familial syndromes, regardless of patient age; OR

        -  Individuals without history of malignancy who are undergoing surgery; OR

        -  Individuals without a history of cancer but evidence of an inherited cancer syndrome
           based on family history and/or other manifestations of a pre-cancerous syndrome (e.g.
           polyposis, plexiform neurofibromas, myelodysplastic disease); OR

        -  Patient enrolled in an approved companion protocol.

        -  Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues)
           that has been previously collected under CLIA and maintained in a CLIA lab which is
           available for CLIA analysis.

        -  Tissue (including tumor, normal, blood, bone marrow, serum, plasma, or other tissues)
           that has been previously collected and is available for research analysis.

        -  Biospecimens can be collected with minimal additional risk to the subject during
           sampling or procedures required for routine patient care.

        -  Individual may be undergoing treatment for malignancy, premalignant condition or
           receiving other care associated with an inherited cancer syndrome.

        -  Patients may be referred to the Principal Investigator from outside institutions.

        -  Ability of subject or Legally Authorized Representative (LAR) to understand and the
           willingness to sign a written informed consent OR

        -  IRB waiver of the requirement for informed consent for specific types of tissue.

      Design:

        -  This study will allow for the collection of specimens for CLIA reporting of germline and
           somatic mutations. The study will also collect specimens for a Tissue Repository, and
           for other investigations as outlined below.

        -  CLIA testing activities will include

             -  DNA extracted from a section of tumor, malignant tissue, blood, or bone marrow
                samples for somatic mutation sequence analysis

             -  Germline DNA extracted from lymphocytes, saliva, skin, or any normal uninvolved
                tissues for sequence analysis to identify somatic alterations in the cancer and for
                the reporting of incidental findings of established clinical validity and utility.

        -  Research activities may include:

             -  DNA, RNA and protein Omics analyses from extracted normal and/or tumor tissues; the
                remainder of the tumor tissue will be stored.

             -  Germline DNA and RNA analyses from extracted lymphocytes or other normal uninvolved
                tissue.

             -  T (TCR) or B Cell Receptor sequencing from blood, tumor, or malignant tissue.

             -  Establishing Patient-Derived Models such as patient-derived xenografts (PDXs),
                early-passage in vitro tumor cultures, and organoid cultures, conditionally
                reprogrammed cells (CRC) lines, explant and cell lines from tumor or normal samples
                by the NCI Patient-Derived Models Repository (PDMR) at Frederick National
                Laboratory for Cancer Research or by the OncoGenomics laboratory.

             -  Cryopreservation of viable normal (e.g. PBMC) or malignant tissues.

             -  Establishment of EBV transformed cell lines from blood for medical research either
                by Coriell Institute or by investigators on this protocol.

             -  Omics (Genomics, Proteomic, Epigenetics, Metabolomics) studies will be performed.

        -  Expected accrual 50-500 patients per year. Total protocol accrual goal 5,000 patients.
observational model: Case-Only
time perspective: Prospective
measure: Identify incidental and secondary findings in germline DNA and actionable somatic mutations for reporting clinical results from a CLIA-certified lab into CRIS medical records.
time frame: ongoing
description: Sample analysis.
measure: Molecular, genomic, epigenetic, transcriptomic, proteomic, metabolomics and other "omics" profiling on tumors, malignancies and normal tissues
time frame: ongoing
description: Sample analysis for identification of biomarkers, drivers and medically actionable targets for clinical management.
measure: Create a tissue repository
time frame: ongoing
description: Repository for analysis of samples.
measure: Extraction and storage of circulating tumor DNA
time frame: ongoing
description: Storage of samples.
measure: Establishing Patient-derived models
time frame: ongoing
description: Analysis of samples.
measure: Cryopreservation of viable tumor tissue for future study
time frame: ongoing
description: Sample storage for future analysis.
measure: Establishment of EBV transformed cell lines for research
time frame: ongoing
description: Analysis of germline samples.
measure: Creation of an OncoGenomics oversight committee
time frame: ongoing
description: Oversight and development of new treatment approaches.
measure: Assessment of effects of the informed consent process
time frame: ongoing
description: Survey data collection and analysis.
arm group label: Group A
description: Adult/pediatric with suspected or confirmed malignancy, family history of malignancy, undergoing surgery with no malignancy; tissues collected previously under CLIA or for research.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 99 Years
healthy volunteers: No
last name: Javed Khan, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-C-0040.html
description: NIH Clinical Center Detailed Web Page
citation: Green RC, Berg JS, Grody WW, Kalia SS, Korf BR, Martin CL, McGuire AL, Nussbaum RL, O'Daniel JM, Ormond KE, Rehm HL, Watson MS, Williams MS, Biesecker LG; American College of Medical Genetics and Genomics. ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med. 2013 Jul;15(7):565-74. doi: 10.1038/gim.2013.73. Epub 2013 Jun 20. Erratum In: Genet Med. 2017 May;19(5):606.
PMID: 23788249
citation: Weiner C. Anticipate and communicate: Ethical management of incidental and secondary findings in the clinical, research, and direct-to-consumer contexts (December 2013 report of the Presidential Commission for the Study of Bioethical Issues). Am J Epidemiol. 2014 Sep 15;180(6):562-4. doi: 10.1093/aje/kwu217. Epub 2014 Aug 22.
PMID: 25150271
citation: Appelbaum PS, Waldman CR, Fyer A, Klitzman R, Parens E, Martinez J, Price WN 2nd, Chung WK. Informed consent for return of incidental findings in genomic research. Genet Med. 2014 May;16(5):367-73. doi: 10.1038/gim.2013.145. Epub 2013 Oct 24.
PMID: 24158054
responsible party type: Sponsor
mesh term: Neurofibroma
mesh term: Adenomatous Polyposis Coli
mesh term: Neurofibroma, Plexiform
mesh term: Myelodysplastic Syndromes