<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/NCT02970045</url>
  </required_header>
  <id_info>
    <org_study_id>0S-15-12</org_study_id>
    <secondary_id>NCI-2016-00770</secondary_id>
    <secondary_id>0S-15-12</secondary_id>
    <secondary_id>P30CA014089</secondary_id>
    <nct_id>NCT02970045</nct_id>
  </id_info>
  <brief_title>Norris ORIEN Total Cancer Care</brief_title>
  <official_title>Norris ORIEN Total Cancer Care Protocol: A Lifetime Partnership With Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This research trial collects biological samples and clinical information to create a&#xD;
      repository of data from patients with cancer or a predisposition for cancer. Combining&#xD;
      genetic information from biological samples and clinical data may lead to more knowledge&#xD;
      about why certain cancers respond to treatment and help create more personalized medicine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To establish a longitudinal study of clinical and related data from patients with or at&#xD;
      risk for cancer.&#xD;
&#xD;
      II. To establish a large biospecimen repository that is linked to clinical and related data.&#xD;
&#xD;
      III. To follow patients through their lifetime though passive or active follow-up.&#xD;
&#xD;
      IV. To use clinical data, tissues, other biological samples and derived molecular data in the&#xD;
      Total Cancer Care Protocol (TCCP) repositories to match patients in this TCCP study to future&#xD;
      studies.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo collection of blood during a regular care visit or not up to 4 times a year.&#xD;
      Extra tissue is collected after removal during standard of care surgery and patients may&#xD;
      undergo additional tumor sampling (needle passes) at the time of planned diagnostic biopsies.&#xD;
      During bone marrow biopsy, the doctor may reposition the needle up to 3 times, and bone&#xD;
      marrow for research will not be collected more than 4 times per year. Patients may undergo&#xD;
      additional collection of other biological samples such as saliva, sputum, urine, feces, hair,&#xD;
      and surface skin swabs for analysis. Patients also receive surveys or questionnaires to&#xD;
      collect demographics, medical, family, and nutritional history, cancer predisposing risk&#xD;
      factors, quality of life data, and quality of care data.&#xD;
&#xD;
      After completion of study, patients are followed up periodically.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 2, 2016</start_date>
  <completion_date type="Anticipated">May 2, 2037</completion_date>
  <primary_completion_date type="Anticipated">May 2, 2036</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>Number of biospecimen collected for a centralized repository that is linked to clinical data</measure>
    <time_frame>Up to 21 years</time_frame>
    <description>Establish and maintain a unique repository of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected from thousands of patients 18 years of age or older who have cancer or are at risk of developing cancer.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Cancer Risk</condition>
  <condition>Malignant Neoplasm</condition>
  <arm_group>
    <arm_group_label>Ancillary-Correlative (biospecimen collection)</arm_group_label>
    <description>Patients undergo collection of blood during a regular care visit or not up to 4 times a year. Extra tissue is collected after removal during standard of care surgery and patients may undergo additional tumor sampling (needle passes) at the time of planned diagnostic biopsies. During bone marrow biopsy, the doctor may reposition the needle up to 3 times, and bone marrow for research will not be collected more than 4 times per year. Patients may undergo additional collection of other biological samples such as saliva, sputum, urine, feces, hair, and surface skin swabs for analysis. Patients also receive surveys or questionnaires to collect demographics, medical, family, and nutritional history, cancer predisposing risk factors, quality of life data, and quality of care data.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo collection of blood, tissue, and other biological samples</description>
    <arm_group_label>Ancillary-Correlative (biospecimen collection)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Evaluation of Cancer Risk Factors</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Ancillary-Correlative (biospecimen collection)</arm_group_label>
    <other_name>cancer risk factors evaluation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical Chart Review</intervention_name>
    <description>Review of medical chart</description>
    <arm_group_label>Ancillary-Correlative (biospecimen collection)</arm_group_label>
    <other_name>Chart Review</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Ancillary-Correlative (biospecimen collection)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Ancillary-Correlative (biospecimen collection)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor tissue, bone marrow, blood, saliva, sputum, urine, feces, hair, surface skin&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with cancer or predisposition for cancer recruited from University of Southern&#xD;
        California/Kenneth Norris, Jr. Comprehensive Cancer Center and Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Limited to those patients who are registered for outpatient or inpatient care at&#xD;
             University of Southern California (USC) Norris&#xD;
&#xD;
          -  Able to understand and sign the TCCP informed consent, California subject's bill of&#xD;
             rights, Health Insurance Portability and Accountability Act (HIPAA), and research&#xD;
             authorization form directly or through an authorized representative; the informed&#xD;
             consent, subject's bill of rights, HIPAA, and research authorization will be available&#xD;
             in both English and Spanish languages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are not registered as patients for outpatient or inpatient care at USC&#xD;
             Norris&#xD;
&#xD;
          -  Individuals who are unable to understand or sign the TCCP informed consent, subject's&#xD;
             bill of rights, HIPAA, and research authorization in either English or Spanish&#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>John Carpten, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Melissa Woodhouse, MHA, MPH</last_name>
    <phone>323-865-0489</phone>
    <email>Melissa.woodhouse@med.usc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Woodhouse, MHA, MPH</last_name>
      <phone>323-865-0489</phone>
      <email>Melissa.woodhouse@med.usc.edu</email>
    </contact>
    <investigator>
      <last_name>John Carpten, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 19, 2022</last_update_submitted>
  <last_update_submitted_qc>November 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT02970045
org study id: 0S-15-12
secondary id: NCI-2016-00770
secondary id: 0S-15-12
secondary id: P30CA014089
nct id: NCT02970045
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research trial collects biological samples and clinical information to create a
      repository of data from patients with cancer or a predisposition for cancer. Combining
      genetic information from biological samples and clinical data may lead to more knowledge
      about why certain cancers respond to treatment and help create more personalized medicine.
PRIMARY OBJECTIVES:

      I. To establish a longitudinal study of clinical and related data from patients with or at
      risk for cancer.

      II. To establish a large biospecimen repository that is linked to clinical and related data.

      III. To follow patients through their lifetime though passive or active follow-up.

      IV. To use clinical data, tissues, other biological samples and derived molecular data in the
      Total Cancer Care Protocol (TCCP) repositories to match patients in this TCCP study to future
      studies.

      OUTLINE:

      Patients undergo collection of blood during a regular care visit or not up to 4 times a year.
      Extra tissue is collected after removal during standard of care surgery and patients may
      undergo additional tumor sampling (needle passes) at the time of planned diagnostic biopsies.
      During bone marrow biopsy, the doctor may reposition the needle up to 3 times, and bone
      marrow for research will not be collected more than 4 times per year. Patients may undergo
      additional collection of other biological samples such as saliva, sputum, urine, feces, hair,
      and surface skin swabs for analysis. Patients also receive surveys or questionnaires to
      collect demographics, medical, family, and nutritional history, cancer predisposing risk
      factors, quality of life data, and quality of care data.

      After completion of study, patients are followed up periodically.
observational model: Case-Only
time perspective: Prospective
measure: Number of biospecimen collected for a centralized repository that is linked to clinical data
time frame: Up to 21 years
description: Establish and maintain a unique repository of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected from thousands of patients 18 years of age or older who have cancer or are at risk of developing cancer.
arm group label: Ancillary-Correlative (biospecimen collection)
description: Patients undergo collection of blood during a regular care visit or not up to 4 times a year. Extra tissue is collected after removal during standard of care surgery and patients may undergo additional tumor sampling (needle passes) at the time of planned diagnostic biopsies. During bone marrow biopsy, the doctor may reposition the needle up to 3 times, and bone marrow for research will not be collected more than 4 times per year. Patients may undergo additional collection of other biological samples such as saliva, sputum, urine, feces, hair, and surface skin swabs for analysis. Patients also receive surveys or questionnaires to collect demographics, medical, family, and nutritional history, cancer predisposing risk factors, quality of life data, and quality of care data.
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo collection of blood, tissue, and other biological samples
arm group label: Ancillary-Correlative (biospecimen collection)
intervention type: Procedure
intervention name: Evaluation of Cancer Risk Factors
description: Ancillary studies
arm group label: Ancillary-Correlative (biospecimen collection)
other name: cancer risk factors evaluation
intervention type: Other
intervention name: Medical Chart Review
description: Review of medical chart
arm group label: Ancillary-Correlative (biospecimen collection)
other name: Chart Review
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Ancillary-Correlative (biospecimen collection)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Ancillary-Correlative (biospecimen collection)
Tumor tissue, bone marrow, blood, saliva, sputum, urine, feces, hair, surface skin
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Carpten, PhD
role: Principal Investigator
affiliation: University of Southern California
last name: Melissa Woodhouse, MHA, MPH
phone: 323-865-0489
email: Melissa.woodhouse@med.usc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms