- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01968538
Metabolomic Study for Localized Prostate Cancer
February 27, 2023 updated by: Georgetown University
A Pilot Study to Establish a Standardized Protocol for Omic Analysis of Patients With Clinically Localized Prostate Cancer Receiving Radiation Therapy
Prostate cancer is a common disease in men treated using surgery, radiation therapy and/or hormonal therapy.
Clinical prognosis relates to stage and grade of disease.
Recent advances in omic analysis may offer additional information to the physician about prognosis and radiation response.
We propose to establish a protocol to incorporate omic analysis into the evaluation and treatment of patients with prostate cancer.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Virginia
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Arlington, Virginia, United States, 22209
- Georgetown University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
200 prostate cancer patients vs. 200 healthy men
Description
Inclusion Criteria:
- Males who are older than 18 years old,
- with clinically localized prostate cancer
- are receiving radiation therapy
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Prostate Cancer Patients
Prostate cancer patients who underwent radiation therapy
|
Other Names:
|
Healthy control
age-matched male who has no known prostate cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
molecular changes in biofluid
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sean P Collins, MD, PhD, Georgetown University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Anticipated)
December 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
September 19, 2013
First Submitted That Met QC Criteria
October 18, 2013
First Posted (Estimate)
October 24, 2013
Study Record Updates
Last Update Posted (Estimate)
February 28, 2023
Last Update Submitted That Met QC Criteria
February 27, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-096
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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