<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/NCT02239575</url>
  </required_header>
  <id_info>
    <org_study_id>GBC PRT0009</org_study_id>
    <nct_id>NCT02239575</nct_id>
  </id_info>
  <brief_title>Collection of Retrospective (Archival) Samples and Prospective Collection of Surplus Tissue and Blood Samples</brief_title>
  <acronym>GBCPRT0009</acronym>
  <official_title>Collection of Retrospective (Archival) Samples and Prospective Collection of Surplus Tissue and Blood Samples</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Global BioClinical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Global BioClinical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will enroll specimens from subjects diagnosed with various cancers and who have&#xD;
      either:&#xD;
&#xD;
        1. RETROSPEFCTIVE / ARCHIVAL SAMPLES already undergone surgical resection of their tumor&#xD;
           and have one or more formalin fixed and paraffin embedded (FFPE) blocks on file within&#xD;
           the local (or affiliated) pathology archive (replicate blocks from same tumor) or blocks&#xD;
           no longer required to be maintained on file - discard blocks, or&#xD;
&#xD;
        2. PROSPECTIVE SAMPLES are scheduled to undergo surgical treatment and who prior to&#xD;
           scheduled surgery, provide informed consent and donate a 10-20 ml blood sample. After&#xD;
           surgery, surplus tissues (including tumor and adjacent normal tissues) not required for&#xD;
           diagnosis will be collected.&#xD;
&#xD;
      Subject clinical information will be collected, including basic demographic information,&#xD;
      medical history, current cancer history and treatment. A final pathology report will be&#xD;
      obtained for each subject's surgical specimen. In some instances, and based on the cancer&#xD;
      indications required, longitudinal data may also be collected at a frequency of every 6&#xD;
      months to once per year. Longitudinal data will include information on study subject survival&#xD;
      and disease recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CANCER INDICATIONS:&#xD;
&#xD;
      Bladder Cancer - Urothelial carcinoma - nonpapillary Bladder Cancer - Urothelial carcinoma -&#xD;
      papillary Brain Cancer - Astrocytoma Brain Cancer - Glioblastoma Brain Cancer -&#xD;
      Medulloblastoma Breast Cancer - Ductal Carcinoma Breast Cancer - Lobular Carcinoma Cervical&#xD;
      Cancer - Squamous Cell Carcinoma Colorectal Cancer - Adenocarcinoma Esophageal Cancer -&#xD;
      Adenocarcinoma Gastric Cancer Head and Neck Cancer - Squamous Cell Carcinoma Hematologic&#xD;
      Cancer - Acute Lymphocytic Leukemia (ALL) Hematologic Cancer - Acute Myeloid Leukemia (AML)&#xD;
      Hematologic Cancer - Chronic Lymphocytic Leukemia (CLL) Hematologic Cancer - Diffuse Large&#xD;
      B-cell Lymphoma Hematologic Cancer - Multiple Myeloma (MM) Hematologic Cancer - Non-Hodgkins&#xD;
      Lymphoma (NHL) Kidney Cancer - Papillary Carcinoma Kidney Cancer - Renal cell Carcinoma Liver&#xD;
      Cancer - Hepatocellular Carcinoma Lung Cancer - Adenocarcinoma Lung Cancer - Squamous Cell&#xD;
      Cancer Melanoma Pancreatic Cancer - Ductal Adenocarcinoma Prostate Cancer - Adenocarcinoma&#xD;
      Sarcomas Thyroid Cancer - Follicular Carcinoma Thyroid Cancer - Papillary Carcinoma Uterine&#xD;
      Cancer - Endometrial Carcinoma&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">February 27, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>Identification and validation of cancer biomarkers in archival formalin fixed and paraffin embedded tumor samples</measure>
    <time_frame>Sample Collection May 2014 to Dec 2016, disease recurrence follow-up periods for upto 1 year</time_frame>
    <description>This study will identify novel cancer biomarkers associated with various solid tumor sub-types, tumor stages, and from patients with various responses to treatment.</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      pre-surgical blood samples and/or surplus surgical oncology tissues&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Surplus surgical specimens from subjects diagnosed with cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any adult age&#xD;
&#xD;
          -  Any sex&#xD;
&#xD;
          -  Able to provide consent for surplus tissue and/or blood donation&#xD;
&#xD;
          -  Diagnosed with one of the cancer indications listed below:&#xD;
&#xD;
          -  Scheduled to undergo surgical resection of tumor (exception for hematological cancers)&#xD;
&#xD;
          -  Have not yet received treatment for cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not diagnosed with required cancer indication&#xD;
&#xD;
          -  Not scheduled to undergo surgical resection of the tumor&#xD;
&#xD;
          -  Have already received cancer treatment (such as chemotherapy, radiation, surgery) for&#xD;
             the current cancer or a previously diagnosed cancer&#xD;
&#xD;
          -  Not able to donate an adequate volume of blood to meet minimum requirements&#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>Neil Mucci</last_name>
    <role>Study Director</role>
    <affiliation>GBC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Global BioClinical</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Assorted cancers (oncology)</keyword>
  <!-- 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/NCT02239575
org study id: GBC PRT0009
nct id: NCT02239575
lead sponsor: 
has dmc: No
This study will enroll specimens from subjects diagnosed with various cancers and who have
      either:

        1. RETROSPEFCTIVE / ARCHIVAL SAMPLES already undergone surgical resection of their tumor
           and have one or more formalin fixed and paraffin embedded (FFPE) blocks on file within
           the local (or affiliated) pathology archive (replicate blocks from same tumor) or blocks
           no longer required to be maintained on file - discard blocks, or

        2. PROSPECTIVE SAMPLES are scheduled to undergo surgical treatment and who prior to
           scheduled surgery, provide informed consent and donate a 10-20 ml blood sample. After
           surgery, surplus tissues (including tumor and adjacent normal tissues) not required for
           diagnosis will be collected.

      Subject clinical information will be collected, including basic demographic information,
      medical history, current cancer history and treatment. A final pathology report will be
      obtained for each subject's surgical specimen. In some instances, and based on the cancer
      indications required, longitudinal data may also be collected at a frequency of every 6
      months to once per year. Longitudinal data will include information on study subject survival
      and disease recurrence.
CANCER INDICATIONS:

      Bladder Cancer - Urothelial carcinoma - nonpapillary Bladder Cancer - Urothelial carcinoma -
      papillary Brain Cancer - Astrocytoma Brain Cancer - Glioblastoma Brain Cancer -
      Medulloblastoma Breast Cancer - Ductal Carcinoma Breast Cancer - Lobular Carcinoma Cervical
      Cancer - Squamous Cell Carcinoma Colorectal Cancer - Adenocarcinoma Esophageal Cancer -
      Adenocarcinoma Gastric Cancer Head and Neck Cancer - Squamous Cell Carcinoma Hematologic
      Cancer - Acute Lymphocytic Leukemia (ALL) Hematologic Cancer - Acute Myeloid Leukemia (AML)
      Hematologic Cancer - Chronic Lymphocytic Leukemia (CLL) Hematologic Cancer - Diffuse Large
      B-cell Lymphoma Hematologic Cancer - Multiple Myeloma (MM) Hematologic Cancer - Non-Hodgkins
      Lymphoma (NHL) Kidney Cancer - Papillary Carcinoma Kidney Cancer - Renal cell Carcinoma Liver
      Cancer - Hepatocellular Carcinoma Lung Cancer - Adenocarcinoma Lung Cancer - Squamous Cell
      Cancer Melanoma Pancreatic Cancer - Ductal Adenocarcinoma Prostate Cancer - Adenocarcinoma
      Sarcomas Thyroid Cancer - Follicular Carcinoma Thyroid Cancer - Papillary Carcinoma Uterine
      Cancer - Endometrial Carcinoma
observational model: Case-Only
time perspective: Prospective
measure: Identification and validation of cancer biomarkers in archival formalin fixed and paraffin embedded tumor samples
time frame: Sample Collection May 2014 to Dec 2016, disease recurrence follow-up periods for upto 1 year
description: This study will identify novel cancer biomarkers associated with various solid tumor sub-types, tumor stages, and from patients with various responses to treatment.
pre-surgical blood samples and/or surplus surgical oncology tissues
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neil Mucci
role: Study Director
affiliation: GBC
facility: 
country: United States
responsible party type: Sponsor