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Collecting and Storing Blood and Tumor Tissue Samples From Patients Undergoing Prostatectomy or Transurethral Resection of the Prostate

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00991315
Recruitment Status : Terminated (Specimens are now collected through the BRS protocol.)
First Posted : October 8, 2009
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Isaac Yi Kim, MD, PhD, MBA, Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date October 7, 2009
First Posted Date October 8, 2009
Last Update Posted Date April 8, 2021
Actual Study Start Date December 12, 2008
Actual Primary Completion Date April 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2011)
Collection and freezing of tumor samples [ Time Frame: 5 years ]
Original Primary Outcome Measures
 (submitted: October 7, 2009)
Collection and freezing of tumor samples
Change History
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 Collecting and Storing Blood and Tumor Tissue Samples From Patients Undergoing Prostatectomy or Transurethral Resection of the Prostate
Official Title Assessment of Tumor Resistance and Stem Cells in Prostate Cancer
Brief Summary The primary objective of this study is to collect material for study's to assess mechanisms of tumor progression, mechanisms of resistance, isolation of stem cells and biologic markers in tissue, serum and peripheral blood mononuclear cells.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Samples will be collected at time of TURP and will be deidentified and processed by standard procedures.
Sampling Method Non-Probability Sample
Study Population Any patient undergoing a routine prostatectomy or TURP (transurethral resection of the prostate) may be asked to participate
Condition Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Terminated
Actual Enrollment
 (submitted: September 21, 2017)
126
Original Estimated Enrollment
 (submitted: October 7, 2009)
1000
Actual Study Completion Date April 10, 2017
Actual Primary Completion Date April 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Undergoing routine prostatectomy or transurethral resection of the prostate (TURP)

PATIENT CHARACTERISTICS:

5.1.1 Patient is undergoing routine prostatectomy or TURP.

5.1.2 Patient is ≥ 18 years old.

5.1.3 Patient must give informed consent.

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00991315
Other Study ID Numbers 0220080275
P30CA072720 ( U.S. NIH Grant/Contract )
0220080275 ( Other Identifier: IRB # )
080809 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Isaac Yi Kim, MD, PhD, MBA, Rutgers, The State University of New Jersey
Study Sponsor Rutgers, The State University of New Jersey
Collaborators
  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey
Investigators
Principal Investigator: Isaac Kim, MD, PhD Rutgers Cancer Institute of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date April 2021