Clinical Validity and Utility of Genomic-targeted Chemoprevention of PCa: Aim 4a
2 other identifiers
interventional
700
0 countries
N/A
Brief Summary
This study was designed to compare the efficacy, perception, decision making, and cost-effectiveness of genomic and non-genomic approaches for risk assessment of prostate cancer and for chemoprevention of prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Jun 2011
Shorter than P25 for not_applicable prostate-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 28, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedResults Posted
Study results publicly available
November 22, 2019
CompletedNovember 22, 2019
November 1, 2019
1 year
February 28, 2015
June 7, 2016
November 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants Who Had Prostate Specific Antigen (PSA) Discussion With Physician at 3 Months, Measured by Survey
Discussion with Physician regarding PSA screening, measured by survey 3 months after provision of risk information
3 months
Number of Participants Who Had PSA Testing at 3 Months, Measured by Survey
PSA screening, measured by survey 3 months after provision of risk information.
3 months
Number of Participants Who Had PSA Testing at 3 Years, Measured by Medical Records
PSA screening, measured by medical records 3 years after provision of risk information.
3 years
Secondary Outcomes (3)
Anxiety, Measured by State-trait Anxiety Inventory (STAI)
Baseline
Accuracy of Immediate Recall of Risk Information Measured by Survey
Baseline
Accuracy of Recall of Risk Information at 3 Months Measured by Survey
3 month
Study Arms (4)
Genetic Risk Score: Number Format
EXPERIMENTALGenetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.
Genetic Risk Score: Number + Pictograph
EXPERIMENTALGenetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.
Family History: Number Format
EXPERIMENTALFamily History: Number Format Subjects receive family history risk in a number format.
Family History: Number + Pictograph
EXPERIMENTALFamily History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.
Interventions
Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number.
Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
Eligibility Criteria
You may qualify if:
- age 40 to 49 years, self-defined Caucasian background, and no prior prostate specific antigen (PSA) screening nor prostate cancer (PCa) diagnosis.
You may not qualify if:
- outside of age range, or not self defined Caucasian background, or a prior history of PSA screening or PCa diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Endeavor Healthlead
- Van Andel Research Institutecollaborator
- Spectrum Health Medical Groupcollaborator
- National Cancer Institute (NCI)collaborator
- Wake Forest University Health Sciencescollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Aubrey R. Turner
- Organization
- Wake Forest University Health Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Jianfeng Xu, Dr.P.H.
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Human Genomics and Personalized Medicine, Epidemiology, Cancer Biology, and Urology
Study Record Dates
First Submitted
February 28, 2015
First Posted
March 6, 2015
Study Start
June 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
November 22, 2019
Results First Posted
November 22, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share
There is no intent to share individual participant data (IPD). The terms included in the study consent form do not allow sharing of IPD.