Study of Blood Samples From Older Patients at High Risk of Developing Prostate Cancer and From Healthy Male Participants

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00898274
First received: May 9, 2009
Last updated: May 16, 2012
Last verified: May 2012

May 9, 2009
May 16, 2012
January 2008
September 2012   (final data collection date for primary outcome measure)
  • Plasma levels of antioxidant enzymes as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay [ Time Frame: at time of study entry ] [ Designated as safety issue: No ]
    Blood (5ml) will be drawn from subjects for use in the various assays.
  • Oxidative DNA damage as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay [ Time Frame: at time of study entry ] [ Designated as safety issue: No ]
    Blood (5ml) will be drawn from subjects for use in the various assays.
  • Plasma levels of antioxidant enzymes as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay [ Designated as safety issue: No ]
  • Oxidative DNA damage as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00898274 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Blood Samples From Older Patients at High Risk of Developing Prostate Cancer and From Healthy Male Participants
Antioxidant Enzymes and Oxidative DNA Damage in Subjects With 'High-Risk' for Prostate Cancer

RATIONALE: Studying samples of blood in the laboratory from patients who are at high risk of developing prostate cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples from patients at high risk of developing prostate cancer and from healthy male participants.

OBJECTIVES:

  • To determine whether there are any changes in pro-oxidant-antioxidant profiles in patients who are at high risk for developing prostate cancer.
  • To compare the profiles of these patients with those of healthy controls.

OUTLINE: Participants undergo blood sample collection. Samples are used to measure levels of antioxidant enzymes (i.e., glutathione, glutathione peroxidase, glutathione reductase, superoxide dismutase, and reduced glutathione) and biomarkers of oxidative stress and DNA damage in leukocytes (i.e., thiobarbituric acid reactive substances [TBARS] and 8-hydroxydeoxyguanosine). Samples are analyzed via antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay.

PROJECTED ACCRUAL: A total of 40 participants (20 at high risk for developing prostate cancer and 20 healthy controls) will be accrued for this study.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples from patients at high risk of developing prostate cancer and from healthy male participants.

Probability Sample

Primary Care Clinic

  • Precancerous Condition
  • Prostate Cancer
  • Other: immunoenzyme technique
    Participants undergo blood sample collection. Samples are used to measure levels of antioxidant enzymes (i.e., glutathione, glutathione peroxidase, glutathione reductase, superoxide dismutase, and reduced glutathione) and biomarkers of oxidative stress and DNA damage in leukocytes (i.e., thiobarbituric acid reactive substances [TBARS] and 8-hydroxydeoxyguanosine). Samples are analyzed via antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay.
  • Other: laboratory biomarker analysis
    Participants undergo blood sample collection. Samples are used to measure levels of antioxidant enzymes (i.e., glutathione, glutathione peroxidase, glutathione reductase, superoxide dismutase, and reduced glutathione) and biomarkers of oxidative stress and DNA damage in leukocytes (i.e., thiobarbituric acid reactive substances [TBARS] and 8-hydroxydeoxyguanosine). Samples are analyzed via antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay.
  • High risk for developing prostate cancer
    Male subjects age 45-65 at high risk for developing prostate cancer.
    Interventions:
    • Other: immunoenzyme technique
    • Other: laboratory biomarker analysis
  • Healthy participants
    Aged matched healthy participants
    Interventions:
    • Other: immunoenzyme technique
    • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
Not Provided
September 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Patient at high risk for developing prostate cancer, due to 1 of the following risk factors:

      • Histologically confirmed proliferative inflammatory atrophy and/or high-grade prostatic intraepithelial neoplasia lesions accompanied by chronic intraprostatic inflammation
      • Abnormality observed during digital rectal exam or transrectal ultrasonography
      • Continued elevated age-adjusted prostate-specific antigen (PSA) meeting at least 1 of the following criteria:

        • Screening PSA > 4.0 ng/mL
        • Free PSA < 18%
        • PSA velocity > 0.75 ng/mL within the past year
    • Healthy volunteer meeting the following criteria:

      • Age-matched
      • Normal PSA level (≤ 2.1 ng/mL)
      • Normal digital rectal exam
      • No prostatitis or benign prostate hyperplasia
      • No urinary symptoms (diagnosed or undiagnosed)
  • No diagnosis of cancer

PATIENT CHARACTERISTICS:

Patients and healthy controls:

  • No chronic inflammatory conditions, especially those for which regular use of non-steroidal anti-inflammatory medications (NSAIDs) is prescribed/recommended, including any of the following:

    • Coronary heart disease
    • Chronic obstructive pulmonary disease (COPD)
    • Psoriasis
    • Pelvic inflammatory disease
    • Multiple sclerosis
    • Arthritis
    • Lupus
    • Hashimoto thyroiditis
    • Inflammatory bowel disease (i.e., ulcerative colitis or Crohn disease)

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy or surgery to the prostate (healthy controls)
Male
45 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00898274
CASE11807, P30CA043703, CASE11807
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Sanjay Gupta, PhD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP