Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass

Ovarian Cancer Clinical Trial

Official title:

Pelvic Mass Study to Develop Serum Proteomic Profiles (SIGNATURES) for Epithelial Ovarian Cancer Diagnosis and Prognosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00238342
• Other study ID #: CDR0000445437
• Secondary ID: GOG-0220
• Status: Active, not recruiting
• Phase: N/A
• First received: October 12, 2005
• Last updated: February 6, 2010
• Start date: October 2005

Study information

• Verified date: April 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Finding specific proteins in the blood may help doctors tell whether a patient has ovarian cancer.

PURPOSE: This clinical trial is studying how well proteomic profiling works in diagnosing ovarian cancer in patients who are undergoing surgery for an abnormal pelvic mass.

Description:

OBJECTIVES:

Primary

• Generate and validate a serum proteomic profile that can predict the presence of invasive ovarian epithelial cancer using preoperative serum specimens obtained from patients undergoing surgical evaluation for an abnormal pelvic mass.

Secondary

• Generate a proteomic profile that can distinguish early- from late-stage invasive ovarian epithelial cancer using preoperative serum specimens from patients who are subsequently diagnosed with invasive ovarian epithelial cancer.

Tertiary

• Determine whether serum proteomic profiling can predict the presence of postoperative residual disease in these patients.

• Determine whether serum proteomic profiling can predict prognosis in these patients.

OUTLINE: This is a pilot, two-part, multicenter study.

• Part A: Within 3 weeks prior to surgical evaluation, patients undergo collection of serum specimen for proteomic profiling using surface-enhanced or matrix-associated laser desorption ionization spectrometry-time of flight detection (SELDI/MALDI-TOF). Patients then undergo surgical evaluation (i.e., biopsy and/or resection) of the pelvic mass. Patients who are diagnosed with invasive ovarian epithelial adenocarcinoma or papillary serous fallopian tube carcinoma (no low malignant potential tumors) AND are without postoperative infection proceed to part B of the study.

• Part B: Patients undergo collection of postoperative serum specimen for proteomic profiling using SELDI/MALDI-TOF within 3-8 weeks after surgery, before starting chemotherapy, and at end of chemotherapy.

After completion of study procedures, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Abnormal pelvic mass by physical examination or imaging test

• Undiagnosed

• Planning to undergo surgical evaluation within the next 3 weeks

PATIENT CHARACTERISTICS:

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Surgery

• See Disease Characteristics

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Genetic:
• proteomic profiling

Other:
• surface-enhanced laser desorption/ionization-time of flight mass spectrometry

Procedure:
• biopsy

Locations

Country	Name	City	State
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	Auburn Regional Center for Cancer Care	Auburn	Washington
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham	Birmingham	Alabama
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Providence Saint Joseph Medical Center - Burbank	Burbank	California
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	Aultman Hospital Cancer Center at Aultman Health Foundation	Canton	Ohio
United States	Providence Centralia Hospital	Centralia	Washington
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	University of Virginia Cancer Center at UV Health System	Charlottesville	Virginia
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	MetroHealth's Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Union Hospital Cancer Program at Union Hospital	Elkton Md	Maryland
United States	Highlands Oncology Group - Fayetteville	Fayetteville	Arkansas
United States	Washington Regional Medical Center	Fayetteville	Arkansas
United States	St. Francis Hospital	Federal Way	Washington
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Florida Gynecologic Oncology - Fort Myers	Fort Myers	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	Metro Health Hospital	Grand Rapids	Michigan
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Gynecologic Oncology Network	Greenville	North Carolina
United States	Leo W. Jenkins Cancer Center at ECU Medical School	Greenville	North Carolina
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	St. Vincent Indianapolis Hospital	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Howard Community Hospital at Howard Regional Health System	Kokomo	Indiana
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida
United States	Women's Cancer Center - Las Vegas	Las Vegas	Nevada
United States	Beebe Medical Center	Lewes	Delaware
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California
United States	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey
United States	Lake/University Ireland Cancer Center	Mentor	Ohio
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Carol G. Simon Cancer Center at Morristown Memorial Hospital	Morristown	New Jersey
United States	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus	New Britain	Connecticut
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington
United States	Methodist Cancer Center at Methodist Hospital - Omaha	Omaha	Nebraska
United States	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California
United States	Chicago Gynecologic Oncology	Palatine	Illinois
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Williamette Gynecologic Oncology PC	Portland	Oregon
United States	Women and Infants Hospital of Rhode Island	Providence	Rhode Island
United States	Good Samaritan Cancer Center	Puyallup	Washington
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Saint Mary's Regional Medical Center	Reno	Nevada
United States	Washoe Cancer Services at Washoe Medical Center - Reno	Reno	Nevada
United States	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia
United States	Carilion Gynecologic Oncology Associates	Roanoke	Virginia
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Seton Cancer Institute - Saginaw	Saginaw	Michigan
United States	Saint Louis University Cancer Center	Saint Louis	Missouri
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Saint Joseph Regional Medical Center	South Bend	Indiana
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Siteman Cancer Center at Barnes-Jewish Hospital	St Louis	Missouri
United States	Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph	St. Joseph	Michigan
United States	Bayfront Medical Center	St. Petersburg	Florida
United States	Overlook Hospital	Summit	New Jersey
United States	Allenmore Hospital	Tacoma	Washington
United States	CCOP - Northwest	Tacoma	Washington
United States	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington
United States	St. Clare Hospital	Tacoma	Washington
United States	St. Joseph Medical Center at Franciscan Health System	Tacoma	Washington
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Cancer Care Associates - Midtown Tulsa	Tulsa	Oklahoma
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey
United States	St. John Macomb Hospital	Warren	Michigan
United States	Aurora Women's Pavilion of West Allis Memorial Hospital	West Allis	Wisconsin
United States	Good Samaritan Hospital Medical Center	West Islip	New York
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass)			No