Genetic Susceptibility to Kidney Cancer
| Tracking Information | |||||
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| First Received Date ICMJE | February 26, 2009 | ||||
| Last Updated Date | December 2, 2010 | ||||
| Start Date ICMJE | July 2008 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00854022 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Genetic Susceptibility to Kidney Cancer | ||||
| Official Title ICMJE | Genetic Susceptibility to Renal Cell Carcinoma | ||||
| Brief Summary | This study will further the understanding of the genetic events leading to the development of RCC; explore the genetic basis for genetic instability and how it affects cancer risk; and eventually provide a means of identifying a subgroup of individuals who are most likely to develop RCC. Such individuals may then be targeted for intervention programs such as chemoprevention or dietary modification. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: We will utilize the blood collected to run several laboratory analyses that will assess DNA damage/repair, telomere length, telomerase activity, and other genetic instability as predictors of RCC risk. All information linking this unique identifier to the participant will be kept in a secure location under lock-and-key password protected. In addition, RCC tumor and adjacent normal tissue samples may be obtained from the MDACC Institutional Tissue Bank (ITB) for cases only. The samples obtained will be left over from surgical procedures, so as to prevent any additional distress to the patient. |
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| Sampling Method | Probability Sample | ||||
| Study Population | Adult patients with newly diagnosed (diagnosed within the year of enrollment) with possible Renal Cell Carcinoma (RCC) |
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| Condition ICMJE | Renal Cell Carcinoma | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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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 | 1600 | ||||
| Estimated Completion Date | July 2014 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00854022 | ||||
| Other Study ID Numbers ICMJE | H-17150 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Seth P. Lerner, MD, Baylor College of Medicine | ||||
| Study Sponsor ICMJE | Baylor College of Medicine | ||||
| Collaborators ICMJE | M.D. Anderson Cancer Center | ||||
| Investigators ICMJE |
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| Information Provided By | Baylor College of Medicine | ||||
| Verification Date | December 2010 | ||||
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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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