NYU Ovarian Cancer Early Detection Program Blood and Genetics
| Tracking Information | |||||
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| First Received Date ICMJE | September 18, 2007 | ||||
| Last Updated Date | January 10, 2011 | ||||
| Start Date ICMJE | June 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
identification and development of highly sensitive and specific tumor markers for ovarian cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00531778 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 | NYU Ovarian Cancer Early Detection Program Blood and Genetics | ||||
| Official Title ICMJE | NYU Ovarian Cancer Early Detection Program Blood and Genetics | ||||
| Brief Summary | Improving current strategies for detection of early stage disease can impact favorably on long-term survival of women with ovarian cancer. To reduce the morbidity and mortality of ovarian cancer, screening for this disease must detect early stage disease rather than advanced stage disease. Thus the challenge for the future is to identify and develop highly sensitive and specific tumor markers that can be applied to population-based screening for the early detection of ovarian cancer. |
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| Detailed Description | The aim of NYU Ovarian Cancer Early Detection Program is to establish an effective, early detection program employing state-of-the-art science and technology in collaboration with other nationally recognized clinicians and scientists. This proposed research study will foster collaboration between clinicians and scientists that will facilitate the rapid identification of a set of molecular, biochemical, functional, and genetic markers which can be employed to effectively detect and manage ovarian cancer and other gynecological malignancies. |
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| 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: whole blood, serum, plasma, urine, ovarian tissue |
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| Sampling Method | Probability Sample | ||||
| Study Population | women noted to be at increased risk for developing ovarian cancer |
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| Condition ICMJE | Ovarian Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | NYU OCEDP Population | ||||
| 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 | Terminated | ||||
| Enrollment ICMJE | 890 | ||||
| Completion Date | November 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Women enrolled in the NYU Ovarian Cancer Early Detection Program have at least one of the following risk factors:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00531778 | ||||
| Other Study ID Numbers ICMJE | NYU 04-30 H11938 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Bhavana Pothuri, M.D., NYU Cancer Institute | ||||
| Study Sponsor ICMJE | New York University School of Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | New York University School of Medicine | ||||
| Verification Date | January 2011 | ||||
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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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