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Home > "N" Clinical Trials Conditions > National Ovarian Cancer Early Detection Program Screening and Genetic Study  National Ovarian Cancer Early Detection Program Screening and Genetic Study
National Ovarian Cancer Early Detection Program Screening and Genetic Study
For Condition: stage 2 ovarian epithelial cancer,stage 4 ovarian epithelial cancer,hereditary breast/ovarian cancer (BRCA1, BRCA2),stage 1 ovarian epithelial cancer,stage 3 ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Robert H. Lurie Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Screening and genetic testing may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer. PURPOSE: Clinical trial to determine effective methods of identifying women who are at increased risk for developing ovarian cancer.
Details: OBJECTIVES: - Identify women at increased risk for developing ovarian cancer. - Identify and develop highly sensitive and specific tumor markers for the detection of early rather than advanced stage ovarian cancer. - Develop ovarian cancer specific therapies based on increased understanding of the process of metastatic dissemination using newly developed molecular, genetic, and biochemical insights. - Determine whether the use of minimally invasive office diagnostic laparoscopy and the "Ovarian Pap Test" can accurately differentiate normal, dysplastic, and malignant ovarian epithelium in women at increased risk for developing ovarian cancer. - Determine the utility of molecular technologies to augment cytopathologic investigation in determining epithelial abnormalities in the interpretation of the "Ovarian Pap Test". 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.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Women at increased risk for developing ovarian cancer by one of the following criteria: - Personal history of breast, colon, or urinary cancer - Personal history of ovarian cancer or tumor(s) with at least one ovary remaining after surgery - One or more affected first-degree relatives (mother, sister, or daughter) with ovarian cancer - Multiple family members with either breast and/or ovarian cancer - Personal history of a BRCA-1 or BRCA-2 mutation - An affected first or second-degree relative with BRCA-1 or BRCA-2 mutation - Use of fertility drugs for more than one year OR - Women with diagnosis of ovarian cancer (only Northwestern sites participating) OR benign gynecological condition OR highly suspicious adnexal mass PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidFishman, Study Chair, Robert H. Lurie Cancer Center
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611-3013
United States
Recruiting Northwestern Chicago) Contact Number 312-926-6606 (to speak with a
Additional Information:
Study ID Numbers: CDR0000067757; NU-99G8,NU-99G7,NCI-G00-1753
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005095
Other Hereditary Breast/ovarian Cancer (brca1, Brca2) Studies:
1. Amifostine in Treating Patients With Ovarian Epithelial Cancer Who Are Receiving Chemotherapy
2. Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
3. Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
4. Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
5. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Related Studies:
Other hereditary breast/ovarian cancer (BRCA1, BRCA2) Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
National Ovarian Cancer Early Detection Program Screening and Genetic Study
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