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Biobank for African American Prostate Cancer Research in Florida

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ClinicalTrials.gov Identifier: NCT03232411
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
James and Esther King Biomedical Research Program
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Tracking Information
First Submitted Date July 17, 2017
First Posted Date July 28, 2017
Last Update Posted Date August 8, 2019
Actual Study Start Date February 6, 2017
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 25, 2017)
Number of Complete Patient Data Records Collected at Three Years [ Time Frame: Up to 3 years ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03232411 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 25, 2017)
  • Rate of Impact of Smoking in Prostate Cancer Aggressiveness - All Participants [ Time Frame: Up to 3 years ]
    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.
  • Rate of Impact of Smoking in Prostate Cancer Aggressiveness - Current Smokers [ Time Frame: Up to 3 years ]
    Current smokers further will be classified according to the Pack-year which will be obtained from questionnaire.
  • Number of Participants with Genetic Markers for Smoking Aggressiveness [ Time Frame: Up to 3 years ]
    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.
  • Number of Participants with Epigenetic Markers for Smoking Aggressiveness [ Time Frame: Up to 3 years ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biobank for African American Prostate Cancer Research in Florida
Official Title Biobank for African American Prostate Cancer Research in Florida
Brief Summary

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.

Detailed Description 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva samples and tumor tissue samples.
Sampling Method Non-Probability Sample
Study Population Men of African Ancestry in Florida who were diagnosed with prostate cancer between January 2013 and December 2015.
Condition Prostate Cancer
Intervention
  • Other: Questionnaires
    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.
  • Other: Saliva Samples
    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.
  • Other: Tumor Tissue
    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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 25, 2017)
2700
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The initial recruitment of cases will be done with 3 mailings: the first to introduce the study to the participant from Florida Cancer Data System (FCDS) of the Florida Department of Health and ask them to complete the eligibility form and contact information update form; a second mailing to those who are determined to be eligible for the study to obtain the Informed Consent Form and the Baseline survey; and a third mailing to those who completed the survey to obtain a saliva sample and medical release form for tissue.
  • Histologically biopsy confirmed, primary prostate cancer, diagnosed between January 2013 and December 2015
  • African American or Black; Hispanic Black; Afro-Caribbean
  • Are at least 20 years old
  • Are a resident of Florida
  • Additional criteria may apply

Exclusion Criteria:

  • Does not meet Inclusion Criteria
Sex/Gender
Sexes Eligible for Study: Male
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03232411
Other Study ID Numbers MCC-18643
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators James and Esther King Biomedical Research Program
Investigators
Principal Investigator: Jong Park, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date August 2019