Study of Blood Samples From Older Patients at High Risk of Developing Prostate Cancer and From Healthy Male Participants
NCT ID: NCT00898274
Last Updated: 2016-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2008-01-31
2011-05-31
Brief Summary
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PURPOSE: This research study is looking at blood samples from patients at high risk of developing prostate cancer and from healthy male participants.
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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High risk for developing prostate cancer
Male subjects age 45-65 at high risk for developing prostate cancer.
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.
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.
Healthy participants
Aged matched healthy participants
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
45 Years
65 Years
MALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sanjay Gupta, PhD
Role: STUDY_CHAIR
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Locations
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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
University Suburban Health Center
Cleveland, Ohio, United States
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE11807
Identifier Type: OTHER
Identifier Source: secondary_id
CASE11807
Identifier Type: -
Identifier Source: org_study_id
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