Biobank for African American Prostate Cancer Research in Florida

NCT ID: NCT03232411

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 592 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-22
• Study Completion Date: 2024-01-23

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

James and Esther King Biomedical Research Program

OTHER

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jong Park, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Related Links

https://www.moffitt.org/clinical-trials-research/clinical-trials/?gclid=EAIaIQobChMImIymzIa-9gIVAZ2GCh3uzAWJEAAYASAAEgI0ovD_BwE

Moffitt Cancer Center Clinical Trials website

Other Identifiers

MCC-18643

Identifier Type: -

Identifier Source: org_study_id