Biomarker 11-dh-TXB2 in Blood and Urine Samples From Patients With Prostate Cancer and Healthy Volunteers
This study has been completed.
Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00984919
First received: September 24, 2009
Last updated: April 11, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.
PURPOSE: This research study is looking at a biomarker, 11-dh-TXB2, in blood and urine samples from patients with prostate cancer and healthy volunteers.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Other: high performance liquid chromatography Other: laboratory biomarker analysis Other: mass spectrometry |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Pilot Study of the Role of 11-dh-TXB2 in Prostate Cancer Screening and Diagnosis |
Resource links provided by NLM:
Further study details as provided by Barbara Ann Karmanos Cancer Institute:
Primary Outcome Measures:
- Identification of 11-dh-TXB2 in the blood and urine [ Time Frame: 2 to 4 months ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | November 2009 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To identify a potential novel marker of prostate cancer in the blood and urine, 11-dh-TXB2, to be used as a screening tool for prostate cancer as well as in detection of early relapse in patients previously treated for early-stage prostate cancer.
OUTLINE: Blood and urine samples are collected and analyzed for plasma and urinary 11-dh-TXB2 levels by HPLC and tandem-mass spectrometry.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Cancer clinic
Criteria
DISEASE CHARACTERISTICS:
Meets one of the following criteria:
Histopathologically confirmed prostate cancer meeting 1 of the following criteria:
- Newly diagnosed untreated disease
- Received prior local therapy (prostatectomy, definitive radiotherapy, brachytherapy, or cryotherapy) with no evidence of disease activity (defined as serum PSA < 0.4 ng/mL post therapy) and by imaging studies
- Experienced biochemical failure (defined as rise in serum PSA ≥ 0.4 ng/mL post therapy)
- Healthy volunteer (clinic patient with no history of clinically significant malignancies within the past 6 months)
PATIENT CHARACTERISTICS:
- No clinical evidence of liver cirrhosis or chronic liver disease (i.e., evidence of ascites or severe coagulopathy)
- No active prostatitis
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 30 days since prior and no concurrent regular antiplatelet agents (including aspirin, anagrelide, cilastazole, clopidogrel, dipyridamole, pentoxiphylline, sulfinpyrazone, or ticlopidine)
- More than 7 days since prior and no concurrent NSAIDs (including ibuprofen, celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, indomethacin, ketoprofen, meclofenamate, mefenamic acid, nabumetone, naproxen, oxaprozin, piroxicam, sulindac, or tolmetin)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984919
Locations
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
| Principal Investigator: | Elisabeth I. Heath, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00984919 History of Changes |
| Other Study ID Numbers: | CDR0000654093, P30CA022453, WSU-2009-058 |
| Study First Received: | September 24, 2009 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
|
recurrent prostate cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV 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 May 19, 2013