Biobank for African American Prostate Cancer Research in Florida

December 3, 2025 updated by: H. Lee Moffitt Cancer Center and Research Institute

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
592

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 3 years
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.
Up to 3 years
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.
Up to 3 years
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.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
James and Esther King Biomedical Research Program

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jong Park, Ph.D., H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCC-18643

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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