- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06355336
Real World Prostate Cancer Registry (RWPCR)
Patient Reported Data on Prostate Cancer Diagnosis, Management, and Outcome: Real World Prostate Cancer Registry
Prostate cancer is the most common cancer diagnosed in men in the USA with 268,490 cases diagnosed in 2022 constituting 27% of male cancers and 34,500 deaths (11%) occurred in same year.1 Prostate cancer is a very heterogeneous disease that has different presentations, molecular and pathological features, stages, and disease biology. The treatment options are dependent on the disease stage, its features, and the patient's condition and preferences. The disease outcome also varies significantly due to the previous heterogeneity of the features in addition to other social determinants of health.
Therefore, it is critical to obtain real-world data that reflects the actual patterns of prostate cancer presentation, work up, management, and outcome. Real World Prostate Cancer Registry (RWPCR) aims at compiling real world data from patients presented with prostate cancer in the tristate area. The data collection will be prospective and longitudinal including patients' demographics and disease characteristics, work up, management, and outcome.
Study Overview
Status
Conditions
Detailed Description
Real World Prostate Cancer Registry (RWPCR) aims at compiling real world data from patients presented with prostate cancer in the tristate area. The data collection will be prospective and longitudinal including patients' demographics and disease characteristics, work up, management, and outcome.
Primary Objectives: Describing the patterns of prostate cancer presentation, management, and outcome in the studied population Identify any impact of the compiled variables on treatment selection, work up and outcome.
Secondary Objectives: Identify any gaps and variations in the delivery of care, challenges and needs to optimize management of the disease and improve patient's outcome.
Improve awareness and facilitate enrollment into clinical trials and research studies.
Data will be collected directly from patients. This data will be collected over 10 years with three years of enrollment and seven years of follow-up. Patients provide e-consent and then get login credentials to complete the e-forms which can be edited and updated by the patient. 6 monthly reminders will be sent to the patients to complete 6 monthly follow-ups
Research staff may contact patients to offer opportunities to participate in clinical trials if eligible. A gift card will be provided to the patient for the initial survey submission. A gift card will also be provided to the patient for each 6 month follow up submission.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Abdul Jazieh, MD, MPH
- Phone Number: 5137312273
- Email: a.jazieh@cincinnaticanceradvisors.org
Study Contact Backup
- Name: Amy Barber
- Phone Number: 5137312273
- Email: ctcoordinator@iresearchnetwork.com
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45212
- Recruiting
- Cincinnati Cancer Advisors
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Contact:
- Amy Barber
- Phone Number: 5137312273
- Email: ctcoordinator@iresearchnetwork.com
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Principal Investigator:
- Abdul R Jazieh, MD, MPH
-
Contact:
- Dr. Jazieh
- Phone Number: 5137312273
- Email: a.jazieh@cincinnaticanceradvisors.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
All patients with pathologically confirmed primary prostate cancer
Diagnosis since January 1st, 2023
Acceptance to sign the consent form
18 years old or older
Resident of Ohio, Kentucky or Indiana
Exclusion Criteria:
Having diagnosis of other cancer except squamous cell cancer of the skin
Refusal to sign a consent form.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To determine practice patterns for prostate cancer in the region.
Time Frame: 10 years
|
Descriptive analysis of the disease risk groups, disease stages, and type of treatments provided to the patients (radiation, surgery, hormonal therapy).
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To determine progression free survival and overall survival of patients.
Time Frame: 10 years
|
Percentage of patients participating in clinical trials.
|
10 years
|
|
Prevalence of long term complications of prostate cancer treatment.
Time Frame: 10 years
|
Specifically urine incontinence and erectile dysfunction.
|
10 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCA/IRN-24-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Cancer Institute and Hospital, Chinese Academy...RecruitingProstate Cancer Castration-resistant Prostate CancerChina
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National Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
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Washington University School of MedicineThe Society of Nuclear Medicine and Molecular ImagingNot yet recruitingRecurrent Prostate Cancer | Prostate Cancer | Metastatic Prostate Cancer | Prostate Cancer Recurrent | Prostate Cancer MetastaticUnited States