Biobank for African American Prostate Cancer Research in Florida

NCT03232411 | Completed

• 1 other identifier: MCC-18643
• Study Type: observational
• Target: 592
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate disease; prostatic neoplasm; biobank; prostate cancer in black males; biospecimen; smoking and the aggressiveness of prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Complete Patient Data Records Collected at Three 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 Outcomes (4)

• Rate of Impact of Smoking in Prostate Cancer Aggressiveness - All Participants

  Up to 3 years

• Rate of Impact of Smoking in Prostate Cancer Aggressiveness - Current Smokers

  Up to 3 years

• Number of Participants with Genetic Markers for Smoking Aggressiveness

  Up to 3 years

• Number of Participants with Epigenetic Markers for Smoking Aggressiveness

  Up to 3 years

Interventions

Questionnaires OTHER

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.

Saliva Samples OTHER

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.

Tumor Tissue OTHER

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• James and Esther King Biomedical Research Program: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples and tumor tissue samples.

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Diseases; Smoking

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jong Park, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 28, 2017
• Study Start: March 22, 2017
• Primary Completion: December 30, 2022
• Study Completion: January 23, 2024
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)