Precancerous ConditionNCT00898274
Study of Blood Samples From Older Patients at High Risk of Developing Prostate Cancer and From Healthy Male Participants
An observational study of Precancerous Condition and Prostate Cancer, run by Case Comprehensive Cancer Center at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Precancerous Condition, Prostate Cancer
- What is being tested?
- immunoenzyme technique and laboratory biomarker analysis
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2008to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary Care Clinic
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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
University Suburban Health Center
Cleveland, Ohio, 44121
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, 44122
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Precancerous Condition, Prostate Cancer
- Being tested
- immunoenzyme technique, laboratory biomarker analysis
- Keywords
- prostate cancer, high grade prostatic intraepithelial neoplasia
- Medical subject headings
- Precancerous Conditions, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunoenzyme techniqueOther
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 analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High risk for developing prostate cancer | Male subjects age 45-65 at high risk for developing prostate cancer. Receives: Other: immunoenzyme technique; Other: laboratory biomarker analysis | |
| Healthy participants | Aged matched healthy participants Receives: Other: immunoenzyme technique; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of antioxidant enzymes as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay
Blood (5ml) will be drawn from subjects for use in the various assays.
Measured: at time of study entry
Oxidative DNA damage as assessed by antioxidant enzyme assay, TBARS assay, and enzyme-linked immunosorbent assay
Blood (5ml) will be drawn from subjects for use in the various assays.
Measured: at time of study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJan 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precancerous ConditionStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sanjay Gupta, PhD, Study chair, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898274
- Sponsor's protocol ID
- CASE11807
- Other IDs
- P30CA043703, CASE11807
- Status last verified
- Mar 2016
- First submitted
- 9 May 2009
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidant Enzymes and Oxidative DNA Damage in Subjects With 'High-Risk' for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00898274
- Acronym / sponsor ID
- CASE11807
- Conditions
- Precancerous Condition, Prostate Cancer
- Keywords
- prostate cancer, high grade prostatic intraepithelial neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk for developing prostate cancer | – | Other: immunoenzyme technique, Other: laboratory biomarker analysisMale subjects age 45-65 at high risk for developing prostate cancer. |
| Healthy participants | – | Other: immunoenzyme technique, Other: laboratory biomarker analysisAged matched healthy participants |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunoenzyme techniqueParticipants 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 | Healthy participants, High risk for developing prostate cancer |
| laboratory biomarker analysisParticipants 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 | Healthy participants, High risk for developing prostate cancer |
Primary outcome
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
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
Blood (5ml) will be drawn from subjects for use in the various assays.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Gupta, PhD study chair
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Precancerous Condition and Prostate Cancer, run by Case Comprehensive Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016.