Active Surveillance for Cancer of the Prostate (ASCaP)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of California, Los Angeles.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of California, Los Angeles
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00949819
First received: July 29, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 29, 2009 | ||||||||
| Last Updated Date | July 29, 2009 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Discover and confirm clinical parameters that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables. [ Time Frame: not specified ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Determine the clinical predictors of disease progression. Measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer. Determine factors that lead to active intervention [ Time Frame: not specified ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Active Surveillance for Cancer of the Prostate (ASCaP) | ||||||||
| Official Title ICMJE | The UCLA ASCAP Project is an Observational, Longitudinal, and Open-ended Study Aimed at Establishing a Structured Program of Non-interventional Follow-up for Localized Prostate Cancer. | ||||||||
| Brief Summary | Active Surveillance (A.S.) of prostate cancer (CaP) is the systematic monitoring of men with low-risk, localized lesions, with curative treatment of those whose tumors show substantial progression. A.S. is different from Watchful Waiting (W.W.), which is the palliative treatment of men with progressive prostate cancer. |
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| Detailed Description | This protocol is not designed as a formal clinical trial, but rather an observational protocol; no treatments and no randomization are included. Longitudinally, specimens and clinical data will be collected to provide information on the following:
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Ecologic or Community Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Serum, plasma, buffy coat, prostate tissue cores and urine. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Community sample |
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| Condition ICMJE | Prostate Cancer | ||||||||
| Intervention ICMJE | Other: Observational
Serial, long term data collection |
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| Study Group/Cohort (s) | low-risk prostate cancer
Men with previously untreated, early stage prostate cancer.
Intervention: Other: Observational |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 6 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 30 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00949819 | ||||||||
| Other Study ID Numbers ICMJE | ASCaP | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Leonard S. Marks, M.D., UCLA | ||||||||
| Study Sponsor ICMJE | University of California, Los Angeles | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, Los Angeles | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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