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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. completion date
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


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
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