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

Treatment or Intervention

stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer hereditary breast/ovarian cancer (BRCA1, BRCA2)

Procedure: biological markers  Procedure: chromosomal translocation  Procedure: comparative genomic analysis  Procedure: cytogenetic analysis  Procedure: cytologic sampling  Procedure: diagnostic test  Procedure: genetic analysis  Procedure: microsatellite instability  Procedure: mutation analysis  Procedure: ovarian Pap test  Procedure: polymerase chain reaction  Procedure: polymorphic microsatellite markers  Procedure: screening intervention  Procedure: study of high risk factors

Further Study 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Illinois
      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611-3013,  United States; Recruiting

Study chairs or principal investigators

Lee P. Shulman, MD,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000067757; NU-99G8; NU-99G7; NCI-G00-1753; NCT00005095
Record last reviewed:  November 2004
Last Updated:  February 7, 2005
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005095
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08