Clinical trial NCT03232411: Biobank for African American Prostate Cancer Research in Florida
Official title: Biobank for African American Prostate Cancer Research in Florida
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate disease
prostatic neoplasm
biobank
prostate cancer in black males
biospecimen
smoking and the aggressiveness of prostate cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: James and Esther King Biomedical Research Program
First posted: 2017-07-28
Enrollment: 592
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Number of Complete Patient Data Records Collected at Three Years
timeFrame: Up to 3 years
Secondary outcomes:
measure: Rate of Impact of Smoking in Prostate Cancer Aggressiveness - All Participants
timeFrame: Up to 3 years
measure: Rate of Impact of Smoking in Prostate Cancer Aggressiveness - Current Smokers
timeFrame: Up to 3 years
measure: Number of Participants with Genetic Markers for Smoking Aggressiveness
timeFrame: Up to 3 years
measure: Number of Participants with Epigenetic Markers for Smoking Aggressiveness
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Jong Park, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: