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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00991315
First received: October 7, 2009
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. Storing samples to test in the laboratory may help the study of cancer in the future.

PURPOSE: This research study is collecting and storing blood and tumor tissue samples from patients undergoing prostatectomy or transurethral resection of the prostate.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Tumor Resistance and Stem Cells in Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Collection and freezing of tumor samples [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Samples will be collected at time of TURP and will be deidentified and processed by standard procedures.


Estimated Enrollment: 100
Study Start Date: December 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Collect prostate tissue and other biological specimens for assessment of biological markers that may relate to tumor progression and resistance and for future isolation of stem cells and biologic markers.

Biological samples, including serum and mononuclear cells and tumor tissue, are collected before and during surgery. Specimens are frozen and stored indefinitely.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991315

Locations
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Isaac Kim, MD, PhD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Isaac Kim, Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
ClinicalTrials.gov Identifier: NCT00991315     History of Changes
Other Study ID Numbers: CDR0000648129, P30CA072720, CINJ-080809
Study First Received: October 7, 2009
Last Updated: May 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 18, 2014