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History of Changes for Study: NCT00005095
National Ovarian Cancer Early Detection Program Screening and Genetic Study
Latest version (submitted September 29, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 September 8, 2005 Conditions, Study Status and Study Identification
3 April 19, 2006 Study Status and Study Identification
4 June 7, 2006 Study Status
5 July 13, 2006 Conditions, Groups and Interventions and Study Status
6 September 29, 2006 Study Status
7 November 8, 2006 Study Design, Conditions, Study Status and Study Identification
8 January 5, 2007 Study Status and Conditions
9 January 11, 2007 Study Status and Conditions
10 January 16, 2007 Study Status
11 February 20, 2007 Eligibility and Study Status
12 March 5, 2007 Eligibility and Study Status
13 June 4, 2007 Study Status
14 August 6, 2007 Groups and Interventions, Study Status and Study Identification
15 October 17, 2007 Groups and Interventions and Study Status
16 October 19, 2007 Groups and Interventions and Study Status
17 October 25, 2007 Groups and Interventions and Study Status
18 November 2, 2007 Groups and Interventions and Study Status
19 November 6, 2007 Groups and Interventions and Study Status
20 November 16, 2007 Study Status
21 January 20, 2008 Study Design and Study Status
22 April 22, 2008 Study Status
23 May 23, 2008 Groups and Interventions and Study Status
24 July 23, 2008 Study Design and Study Status
25 December 16, 2008 Study Status
26 February 6, 2009 Groups and Interventions and Study Status
27 July 7, 2009 Study Status
28 October 29, 2009 Contacts/Locations and Study Status
29 November 26, 2009 Groups and Interventions, Conditions, Study Description, Eligibility, Outcome Measures, Study Status and Study Identification
30 February 25, 2011 Study Identification, Study Design, Groups and Interventions, Eligibility, Outcome Measures, Sponsor/Collaborators, Study Status, Conditions and Oversight
31 October 19, 2012 Sponsor/Collaborators, Eligibility, Groups and Interventions, Study Description, Study Status, Study Identification, Study Design and Conditions
32 May 14, 2013 Study Status
33 December 10, 2013 Study Status
34 April 2, 2014 Study Status
35 November 24, 2014 Study Status
36 July 7, 2015 Study Status
37 September 29, 2016 Recruitment Status and Study Status
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Study NCT00005095
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: CDR0000067757
Brief Title: National Ovarian Cancer Early Detection Program Screening and Genetic Study
Official Title: National Ovarian Cancer Early Detection Program: Screening and Genetic Study
Secondary IDs: NU-99G8
NU-99G7
NCI-G00-1753
NCT00005095
Open or close this module Study Status
Record Verification: November 2004
Overall Status: Recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: April 6, 2000
First Submitted that
Met QC Criteria:
January 26, 2003
First Posted: January 27, 2003 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Robert H. Lurie Cancer Center
Responsible Party:
Collaborators: National Cancer Institute (NCI)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.

Detailed Description:

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.

Open or close this module Conditions
Conditions: 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)
Keywords:
Open or close this module Study Design
Study Type: Observational
Time Perspective:
Biospecimen Retention:
Biospecimen Description:
Enrollment:
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Intervention Details:
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
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Study Officials: Lee P. Shulman, MD
Study Chair
Robert H. Lurie Cancer Center
Locations: United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
[Recruiting]
Chicago, Illinois, United States, 60611-3013
Contact:Contact: Northwestern (in Chicago) Contact Number 312-926-6606 (to speak with a
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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