Biobank for African American Prostate Cancer Research in Florida
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03232411|
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : August 8, 2019
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Other: Questionnaires Other: Saliva Samples Other: Tumor Tissue|
|Study Type :||Observational|
|Estimated Enrollment :||2700 participants|
|Official Title:||Biobank for African American Prostate Cancer Research in Florida|
|Actual Study Start Date :||February 6, 2017|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2020|
- 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.
- 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.
- 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232411
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Jennifer Damonte 813-745-3311 email@example.com|
|Contact: Jong Park, Ph.D. 813-745-1703 firstname.lastname@example.org|
|Principal Investigator: Jong Park, Ph.D.|
|Sub-Investigator: Thomas Sellers, Ph.D.|
|Sub-Investigator: Clement Gwede, Ph.D.|
|Sub-Investigator: Julio Pow-Sang, M.D.|
|Sub-Investigator: Kosj Yamoah, M.D., Ph.D.|
|Principal Investigator:||Jong Park, Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|