xml: <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/NCT06008392</url>
    </required_header>
    <id_info>
      <org_study_id>22-008878</org_study_id>
      <nct_id>NCT06008392</nct_id>
    </id_info>
    <brief_title>INTERogating Cancer for Etiology, Prevention and Therapy Navigation</brief_title>
    <acronym>INTERCEPTioN</acronym>
    <official_title>INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the integration of cancer pan-genetic testing into a&#xD;
        cancer clinical practice and understand both its use and effect in &quot;real world&quot; practice&#xD;
        conditions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2033</completion_date>
    <primary_completion_date type="Anticipated">September 2033</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>50 Years</target_duration>
    <primary_outcome>
      <measure>Genomic sequencing of tumor tissue and blood</measure>
      <time_frame>Baseline; 50 years</time_frame>
      <description>Genomic sequencing of tumor tissue and blood will be performed to determine genomic alterations in germline and somatic cancer-related genes (SNVs, indels, CNVs from DNA and fusions from RNA) to allow the ordering hematologist/oncologist/provider to determine optimal therapy and clinical trial prospective. Researchers across the field of genomic sequencing report findings about new variations in scientific publications and collect it in databases every day. Consequently, any patient's variant of uncertain significance (VUS) result could be reclassified by emerging findings, turning previously unresolved tests into diagnostic answers. Our Translational Omics Program has a system to re-analyze a patient's exome/genome data against these new genetic findings-reviewing data and comparing it with emerging clinical genetic data to facilitate diagnoses.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Cancer</condition>
    <condition>Cancer Gene Mutation</condition>
    <condition>PAN Gene Mutation</condition>
    <arm_group>
      <arm_group_label>Participants with a confirmed cancer diagnosis</arm_group_label>
      <description>Potential participants may be identified through the following sources: patients who will undergo or are currently undergoing clinical evaluation in practices such as, but not limited to, hematology-oncology, gastroenterology-hepatology, radiation-oncology and surgery. Participants will be enrolled in the study indefinitely unless a request to withdraw is made.</description>
    </arm_group>
    <intervention>
      <intervention_type>Genetic</intervention_type>
      <intervention_name>Pan-genomic Testing</intervention_name>
      <description>Participants will be scheduled to review the study specifics, review consent and gather medical information. Once consented, samples will be collected. When the samples are received by Exact Sciences, DNA and RNA will be extracted, and sequencing will be performed. Following pan-genomic testing, participants will receive the full report with results from their care team and results will also be added to the patient's portal. If a germline finding is identified (positive pathogenic variant) the participant will also be referred for a genetic counselor visit. All results from the germline hereditary test will be reviewed by a certified genetic counselor in addition to a review of their pedigree. To help with review of any genetic research findings, the study team may request to obtain genomic data from previous genetic testing (clinical or research based).</description>
      <arm_group_label>Participants with a confirmed cancer diagnosis</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Each participant will have residual/archived tissue and a new blood (or saliva, hair&#xD;
        follicle) sample for pan-genomic testing as per standard of care testing. Additional samples&#xD;
        (including but not limited to tissue, bone marrow, blood, urine, stool, hair follicles, etc)&#xD;
        may be requested/collected to be used for additional genomic and other omics studies.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Participants identified internally to Mayo Clinic will be enrolled. The Mayo Clinic study&#xD;
          team and/or subspecialty teams will identify participants that fulfill enrollment criteria.&#xD;
          Only individuals with a confirmed cancer diagnosis who know they have cancer will be asked&#xD;
          to participate.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Has Mayo Clinic medical record number,&#xD;
  &#xD;
            -  Confirmed cancer diagnosis which is either recurrent, relapsed, refractory,&#xD;
               metastatic, or advanced,&#xD;
  &#xD;
            -  Participant aware of cancer diagnosis,&#xD;
  &#xD;
            -  Able to provide informed consent,&#xD;
  &#xD;
            -  Ability to provide blood, saliva, bone marrow aspirate or hair follicle sample,&#xD;
  &#xD;
            -  Ability to provide archived tissue, Note: if tissue unavailable participant may still&#xD;
               enroll onto the study for the germline collection.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Individuals who have situations that would limit compliance with the study requirements:&#xD;
  &#xD;
            -  Institutionalized (i.e. Federal Medical Prison),&#xD;
  &#xD;
            -  Prior germline genetic testing with a 40+ multi-gene panel within the last 1 year of&#xD;
               enrollment, AND/OR&#xD;
  &#xD;
            -  Prior somatic (250+ gene) testing within the prior 3 months of enrollment&#xD;
  &#xD;
          Note: Women who are pregnant or planning to become pregnant can take part in this study.&#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>Jewel J. Samadder, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Katie M. Gano, M.S.</last_name>
      <phone>480-342-6082</phone>
      <email>Gano.Katherine@mayo.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mayo Clinic in Arizona</name>
        <address>
          <city>Scottsdale</city>
          <state>Arizona</state>
          <zip>85259</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Jewel J. Samadder, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic in Florida</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32224</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Jeremy C. Jones, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic in Rochester</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Mrinal S. Patnaik, M.B.B.S.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Whole Exome Sequencing (WES)</keyword>
    <keyword>Whole Genome Sequencing (WGS)</keyword>
    <keyword>Genetic Testing</keyword>
    <keyword>Genetic Counseling</keyword>
    <keyword>Genomics</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008392
  org study id: 22-008878
  nct id: NCT06008392
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the integration of cancer pan-genetic testing into a
        cancer clinical practice and understand both its use and effect in "real world" practice
        conditions.
  observational model: Cohort
  time perspective: Prospective
  measure: Genomic sequencing of tumor tissue and blood
  time frame: Baseline; 50 years
  description: Genomic sequencing of tumor tissue and blood will be performed to determine genomic alterations in germline and somatic cancer-related genes (SNVs, indels, CNVs from DNA and fusions from RNA) to allow the ordering hematologist/oncologist/provider to determine optimal therapy and clinical trial prospective. Researchers across the field of genomic sequencing report findings about new variations in scientific publications and collect it in databases every day. Consequently, any patient's variant of uncertain significance (VUS) result could be reclassified by emerging findings, turning previously unresolved tests into diagnostic answers. Our Translational Omics Program has a system to re-analyze a patient's exome/genome data against these new genetic findings-reviewing data and comparing it with emerging clinical genetic data to facilitate diagnoses.
  arm group label: Participants with a confirmed cancer diagnosis
  description: Potential participants may be identified through the following sources: patients who will undergo or are currently undergoing clinical evaluation in practices such as, but not limited to, hematology-oncology, gastroenterology-hepatology, radiation-oncology and surgery. Participants will be enrolled in the study indefinitely unless a request to withdraw is made.
  intervention type: Genetic
  intervention name: Pan-genomic Testing
  description: Participants will be scheduled to review the study specifics, review consent and gather medical information. Once consented, samples will be collected. When the samples are received by Exact Sciences, DNA and RNA will be extracted, and sequencing will be performed. Following pan-genomic testing, participants will receive the full report with results from their care team and results will also be added to the patient's portal. If a germline finding is identified (positive pathogenic variant) the participant will also be referred for a genetic counselor visit. All results from the germline hereditary test will be reviewed by a certified genetic counselor in addition to a review of their pedigree. To help with review of any genetic research findings, the study team may request to obtain genomic data from previous genetic testing (clinical or research based).
  arm group label: Participants with a confirmed cancer diagnosis
  Each participant will have residual/archived tissue and a new blood (or saliva, hair
        follicle) sample for pan-genomic testing as per standard of care testing. Additional samples
        (including but not limited to tissue, bone marrow, blood, urine, stool, hair follicles, etc)
        may be requested/collected to be used for additional genomic and other omics studies.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jewel J. Samadder, M.D.
  role: Principal Investigator
  affiliation: Mayo Clinic
  last name: Clinical Trials Referral Office
  phone: 855-776-0015
  email: mayocliniccancerstudies@mayo.edu
  last name: Katie M. Gano, M.S.
  phone: 480-342-6082
  email: Gano.Katherine@mayo.edu
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Sponsor