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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005095 |
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.
Condition | Intervention |
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Hereditary Breast/Ovarian Cancer (brca1, brca2) Ovarian Cancer |
Procedure: chromosomal translocation analysis Procedure: comparative genomic hybridization Procedure: cytology specimen collection procedure Procedure: laboratory biomarker analysis Procedure: laparoscopy Procedure: microsatellite instability analysis Procedure: mutation analysis Procedure: ovarian Papanicolaou test Procedure: polymorphic microsatellite marker analysis Procedure: study of high risk factors |
Study Type: | Interventional |
Study Design: | Screening |
Official Title: | Northwestern Ovarian Cancer Early Detection & Prevention Program |
Estimated Enrollment: | 6000 |
Study Start Date: | March 2000 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Women at increased risk for developing ovarian cancer by one of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611-3013 | |
Contact: Northwestern (in Chicago) Contact Number 312-926-6606 (to speak with a |
Study Chair: | Lee P. Shulman, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000067757, NU-99G8, NU-99G7, NCI-G00-1753 |
Study First Received: | April 6, 2000 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00005095 |
Health Authority: | Unspecified |
ovarian epithelial cancer hereditary breast/ovarian cancer (BRCA1, BRCA2) stage I ovarian epithelial cancer stage II ovarian epithelial cancer |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer |
Genital Diseases, Female Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases |
Urogenital Neoplasms Endocrinopathy Ovarian Diseases Ovarian epithelial cancer Recurrence Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |