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Prostate Metabolomic Study

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ClinicalTrials.gov Identifier: NCT01968538
Recruitment Status : Enrolling by invitation
First Posted : October 24, 2013
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Tracking Information
First Submitted Date September 19, 2013
First Posted Date October 24, 2013
Last Update Posted Date February 15, 2019
Study Start Date January 2009
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 18, 2013)
molecular changes in biofluid [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01968538 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prostate Metabolomic Study
Official Title A Pilot Study to Establish a Standardized Protocol for Omic Analysis of Patients With Clinically Localized Prostate Cancer Receiving Radiation Therapy
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Specimen:For future Research Optional Destruction if requested identifiable Urine yes no yes no Sputum yes no yes no Blood yes no yes no
Sampling Method Non-Probability Sample
Study Population 200 prostate cancer patients vs. 200 healthy men
Condition Prostate Cancer
Intervention Radiation: Radiation Therapy
Other Name: Prostate stereotactic body radiation therapy (SBRT) and intensive modulated radiation therapy (IMRT) or the combination of both (boost)
Study Groups/Cohorts
  • Prostate Cancer Patients
    Prostate cancer patients who underwent radiation therapy
    Intervention: Radiation: Radiation Therapy
  • Healthy control
    age-matched male who has no known prostate cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: October 18, 2013)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Males who are older than 18 years old,
  • with clinically localized prostate cancer
  • are receiving radiation therapy

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01968538
Other Study ID Numbers 2009-096
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Georgetown University
Study Sponsor Georgetown University
Collaborators Not Provided
Investigators
Principal Investigator: Sean P Collins, MD, PhD Georgetown University Hospital
PRS Account Georgetown University
Verification Date February 2019