Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Ovarian Cancer Early Detection Program Screening Study

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Biomarker/Laboratory analysis, Diagnostic, Screening	Active	18 and over	NCI	NU-99G8 NU-99G7, NCI-G00-1753, NCT00005095

Objectives

1. Identify women at increased risk for developing ovarian cancer.
2. Identify and develop highly sensitive and specific tumor markers for the detection of early rather than advanced stage ovarian cancer.
3. Develop ovarian cancer specific therapies based on increased understanding of the process of metastatic dissemination using newly developed molecular, genetic, and biochemical insights.
4. 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.
5. Determine the utility of molecular technologies to augment cytopathologic investigation in determining epithelial abnormalities in the interpretation of the "Ovarian Pap Test".

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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Patient Characteristics:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Expected Enrollment

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.

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.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Lee Shulman, MD, Protocol chair		Ph: (312) 926-6301 Email: l-shulman@northwestern.edu

U.S.A.
Illinois
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Northwestern (in Chicago) Contact Number	Ph:  312-926-6606 (to speak with a nurse clinician)
		Northwestern (in Chicago) Contact Number	Ph:  312-926-8400 (for obtaining written information)

Registry Information
Official Title		Northwestern Ovarian Cancer Early Detection & Prevention Program
Trial Start Date		2000-03-02
Registered in ClinicalTrials.gov		NCT00005095
Date Submitted to PDQ		2000-03-02
Information Last Verified		2008-12-14
NCI Grant/Contract Number		P30-CA60553