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| Tracking Information | |||||
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| First Received Date ICMJE | April 6, 2000 | ||||
| Last Updated Date | October 29, 2009 | ||||
| Start Date ICMJE | March 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00005095 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ovarian Cancer Early Detection Program Screening Study | ||||
| Official Title ICMJE | Northwestern Ovarian Cancer Early Detection & Prevention Program | ||||
| Brief Summary | RATIONALE: Screening and genetic testing may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer. PURPOSE: This clinical trial is studying methods of identifying women who are at increased risk for developing ovarian cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Participants complete quality of life and psychosocial questionnaires at the initial visit. Asymptomatic women without recognized ovarian pathology complete an extensive personal and family medical history questionnaire before the initial visit and meet with a genetic counselor. Blood specimens are collected and analyzed for recently identified experimental ovarian cancer markers such as lysophospholipids (LPA), epidermal growth factor receptors (EGFRs), soluble urinary type plasminogen activator (suPAR), and matrix metalloproteinases (MMPs). Since tumor markers are considered experimental, results are not reported to study participants. "Ovarian Pap Test" is a new diagnostic test to detect pre-cancerous or early changes on the ovaries. Using minimally invasive office laparoscopy, the "Ovarian Pap Test" involves direct visualization of the ovaries and collection of cells from the surface of the ovary and from the peritoneal cavity by the use of a laparoscopic cytologic sampling instrument. Participants who undergo prophylactic bilateral salpingo-oophorectomy have tissue collected for genomic and molecular analysis. Ovarian organ cultures are analyzed for proliferation/apoptosis, cell cycle abnormalities and control defects, and processes of cellular migration and invasion. PCR-based assays specifically focusing on expression of mutant forms of p53, variant EGFRs, telomerase, MMPs, and microsatellite instability are performed. Participants are followed every 6 months. PROJECTED ACCRUAL: A total of 6,000 participants (5,000 at increased risk and 1,000 with newly diagnosed cancer) will be accrued for this study within 5 years. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Screening | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 6000 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00005095 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067757, NU-99G8, NU-99G7, NCI-G00-1753 | ||||
| Study Sponsor ICMJE | Robert H. Lurie Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| 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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