<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/NCT03232411</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-18643</org_study_id>
    <nct_id>NCT03232411</nct_id>
  </id_info>
  <brief_title>Biobank for African American Prostate Cancer Research in Florida</brief_title>
  <official_title>Biobank for African American Prostate Cancer Research in Florida</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>James and Esther King Biomedical Research Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>H. Lee Moffitt Cancer Center and Research Institute</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 purposes of this study are: a) to develop a statewide Biobank for prostate cancer among&#xD;
      men of African Ancestry in Florida and; b) to examine whether smoking increases the&#xD;
      aggressiveness of prostate cancer using several biological approaches.&#xD;
&#xD;
      Investigators plan to contact African American prostate cancer patients regarding&#xD;
      participation. This project has 3 main components. Eligible patients may choose to&#xD;
      participate in any or all parts of the study: Questionnaires; Saliva Samples; Tumor Tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project will create the first state-wide data and biospecimen bank for men of African&#xD;
      ancestry with prostate cancer. The sampling strategy and size of the study population ensure&#xD;
      that the cohorts is representative, enhancing validity of studies based on this resource. In&#xD;
      addition, there are no data on the role of smoking in African American prostate cancer. The&#xD;
      approach to share the resource with Florida prostate cancer researchers is innovative and&#xD;
      possible because the four annual prostate cancer symposiums organized by Moffitt has unified&#xD;
      many Florida prostate cancer researchers who are now well connected and actively&#xD;
      collaborating, as evidenced by publications and funded projects among participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 22, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Complete Patient Data Records Collected at Three Years</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>The study timeline is up to 3 years to collect detailed patients' data, outcome information and bio-specimens from men of African Ancestry with prostate cancer (n=6,000), diagnosed between January 2013 and December 2015.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Impact of Smoking in Prostate Cancer Aggressiveness - All Participants</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Rate of prostate aggressiveness according to the smoking status (never, former, current cigarette smoker, pipe/cigar smoker only) at the time of diagnosis. This smoking status can be dichotomized into current smoker and non-smoker.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Impact of Smoking in Prostate Cancer Aggressiveness - Current Smokers</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Current smokers further will be classified according to the Pack-year which will be obtained from questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Genetic Markers for Smoking Aggressiveness</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Occurrence of genetic changes associated with smoking and aggressiveness in prostate tumor samples. Investigators selected ~200 mutations identified in 12 prostate-cancer related genes (AR, ETS, TP53, PTEN, APC, BRAF, BRCA2, ATM, KRAS, SPOP, ERG and EGFR) based upon preliminary study and literature search. Investigators will perform mutation detection on randomly selected 200 patients and determine their association with aggressiveness and smoking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Epigenetic Markers for Smoking Aggressiveness</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Occurrence of epigenetic changes associated with smoking and aggressiveness in prostate tumor samples. A customized panel of 384 CpG sites will be profiled. 384 candidate CpG sites were selected from 149 sites including 18 multiple differentially methylated regions (DMRs) identified in the preliminary study, 235 sites from previous literatures. Investigators will determine their association with aggressiveness and smoking.</description>
  </secondary_outcome>
  <enrollment type="Actual">592</enrollment>
  <condition>Prostate Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Participants will be asked to complete a baseline questionnaire that asks questions about their demographic information, medical history, and smoking habits when they first enroll in the study. They will also be asked to complete a follow-up questionnaire 2 years later. The questionnaires will each take about 25 minutes to complete.</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saliva Samples</intervention_name>
    <description>Participants will be asked to provide a saliva sample using the saliva kit that will be mailed to them. Detailed instructions for collection will be included in the saliva collection packet.</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tumor Tissue</intervention_name>
    <description>Participants will be asked for permission to obtain a sample of their tumor tissue. Participants will receive a medical release form. Once they complete it and mail it back, investigators will request a small amount of tissue collected during the participant's prostate biopsy (or during their surgery, if they had surgery) from their health care provider.</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva samples and tumor tissue samples.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Men of African Ancestry in Florida who were diagnosed with prostate cancer between January&#xD;
        2013 and December 2015.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The initial recruitment of cases will be done with 3 mailings: the first to introduce&#xD;
             the study to the participant from Florida Cancer Data System (FCDS) of the Florida&#xD;
             Department of Health and ask them to complete the eligibility form and contact&#xD;
             information update form; a second mailing to those who are determined to be eligible&#xD;
             for the study to obtain the Informed Consent Form and the Baseline survey; and a third&#xD;
             mailing to those who completed the survey to obtain a saliva sample and medical&#xD;
             release form for tissue.&#xD;
&#xD;
          -  Histologically biopsy confirmed, primary prostate cancer, diagnosed between January&#xD;
             2013 and December 2015&#xD;
&#xD;
          -  African American or Black; Hispanic Black; Afro-Caribbean&#xD;
&#xD;
          -  Are at least 20 years old&#xD;
&#xD;
          -  Are a resident of Florida&#xD;
&#xD;
          -  Additional criteria may apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not meet Inclusion Criteria&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong Park, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Lee Moffitt Cancer Center and Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center and Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate disease</keyword>
  <keyword>prostatic neoplasm</keyword>
  <keyword>biobank</keyword>
  <keyword>prostate cancer in black males</keyword>
  <keyword>biospecimen</keyword>
  <keyword>smoking and the aggressiveness of prostate cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic 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/NCT03232411
org study id: MCC-18643
nct id: NCT03232411
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purposes of this study are: a) to develop a statewide Biobank for prostate cancer among
      men of African Ancestry in Florida and; b) to examine whether smoking increases the
      aggressiveness of prostate cancer using several biological approaches.

      Investigators plan to contact African American prostate cancer patients regarding
      participation. This project has 3 main components. Eligible patients may choose to
      participate in any or all parts of the study: Questionnaires; Saliva Samples; Tumor Tissue.
This project will create the first state-wide data and biospecimen bank for men of African
      ancestry with prostate cancer. The sampling strategy and size of the study population ensure
      that the cohorts is representative, enhancing validity of studies based on this resource. In
      addition, there are no data on the role of smoking in African American prostate cancer. The
      approach to share the resource with Florida prostate cancer researchers is innovative and
      possible because the four annual prostate cancer symposiums organized by Moffitt has unified
      many Florida prostate cancer researchers who are now well connected and actively
      collaborating, as evidenced by publications and funded projects among participants.
observational model: Case-Only
time perspective: Retrospective
measure: Number of Complete Patient Data Records Collected at Three Years
time frame: Up to 3 years
description: The study timeline is up to 3 years to collect detailed patients' data, outcome information and bio-specimens from men of African Ancestry with prostate cancer (n=6,000), diagnosed between January 2013 and December 2015.
measure: Rate of Impact of Smoking in Prostate Cancer Aggressiveness - All Participants
time frame: Up to 3 years
description: Rate of prostate aggressiveness according to the smoking status (never, former, current cigarette smoker, pipe/cigar smoker only) at the time of diagnosis. This smoking status can be dichotomized into current smoker and non-smoker.
measure: Rate of Impact of Smoking in Prostate Cancer Aggressiveness - Current Smokers
time frame: Up to 3 years
description: Current smokers further will be classified according to the Pack-year which will be obtained from questionnaire.
measure: Number of Participants with Genetic Markers for Smoking Aggressiveness
time frame: Up to 3 years
description: Occurrence of genetic changes associated with smoking and aggressiveness in prostate tumor samples. Investigators selected ~200 mutations identified in 12 prostate-cancer related genes (AR, ETS, TP53, PTEN, APC, BRAF, BRCA2, ATM, KRAS, SPOP, ERG and EGFR) based upon preliminary study and literature search. Investigators will perform mutation detection on randomly selected 200 patients and determine their association with aggressiveness and smoking.
measure: Number of Participants with Epigenetic Markers for Smoking Aggressiveness
time frame: Up to 3 years
description: Occurrence of epigenetic changes associated with smoking and aggressiveness in prostate tumor samples. A customized panel of 384 CpG sites will be profiled. 384 candidate CpG sites were selected from 149 sites including 18 multiple differentially methylated regions (DMRs) identified in the preliminary study, 235 sites from previous literatures. Investigators will determine their association with aggressiveness and smoking.
intervention type: Other
intervention name: Questionnaires
description: Participants will be asked to complete a baseline questionnaire that asks questions about their demographic information, medical history, and smoking habits when they first enroll in the study. They will also be asked to complete a follow-up questionnaire 2 years later. The questionnaires will each take about 25 minutes to complete.
intervention type: Other
intervention name: Saliva Samples
description: Participants will be asked to provide a saliva sample using the saliva kit that will be mailed to them. Detailed instructions for collection will be included in the saliva collection packet.
intervention type: Other
intervention name: Tumor Tissue
description: Participants will be asked for permission to obtain a sample of their tumor tissue. Participants will receive a medical release form. Once they complete it and mail it back, investigators will request a small amount of tissue collected during the participant's prostate biopsy (or during their surgery, if they had surgery) from their health care provider.
Saliva samples and tumor tissue samples.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Jong Park, Ph.D.
role: Principal Investigator
affiliation: H. Lee Moffitt Cancer Center and Research Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms