Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass
Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Unknown status
CT.gov ID
NCT00238342
Collaborator
National Cancer Institute (NCI) (NIH)
2,000
107
18.7
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
2000 participants
Primary Purpose:
Diagnostic
Official Title:
Pelvic Mass Study to Develop Serum Proteomic Profiles (SIGNATURES) for Epithelial Ovarian Cancer Diagnosis and Prognosis
Study Start Date
:
Oct 1, 2005
Anticipated Primary Completion Date
:
Oct 1, 2007
Outcome Measures
Primary Outcome Measures
- Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass) []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | Highlands Oncology Group - Fayetteville | Fayetteville | Arkansas | United States | 72703 |
| 3 | Washington Regional Medical Center | Fayetteville | Arkansas | United States | 72703 |
| 4 | Providence Saint Joseph Medical Center - Burbank | Burbank | California | United States | 91505 |
| 5 | Kaiser Permanente Medical Center - Los Angeles | Los Angeles | California | United States | 90027 |
| 6 | Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 7 | Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | United States | 90095-1781 |
| 8 | Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California | United States | 92868 |
| 9 | George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain | Connecticut | United States | 06050 |
| 10 | Beebe Medical Center | Lewes | Delaware | United States | 19958 |
| 11 | CCOP - Christiana Care Health Services | Newark | Delaware | United States | 19713 |
| 12 | Florida Gynecologic Oncology - Fort Myers | Fort Myers | Florida | United States | 33901 |
| 13 | Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland | Florida | United States | 33805 |
| 14 | Bayfront Medical Center | St. Petersburg | Florida | United States | 33701 |
| 15 | Northwest Community Hospital | Arlington Heights | Illinois | United States | 60005 |
| 16 | Rush-Copley Cancer Care Center | Aurora | Illinois | United States | 60507 |
| 17 | Hinsdale Hematology Oncology Associates | Hinsdale | Illinois | United States | 60521 |
| 18 | Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | United States | 60435 |
| 19 | Chicago Gynecologic Oncology | Palatine | Illinois | United States | 60067 |
| 20 | Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
| 21 | CCOP - Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 22 | Elkhart General Hospital | Elkhart | Indiana | United States | 46515 |
| 23 | St. Vincent Indianapolis Hospital | Indianapolis | Indiana | United States | 46260 |
| 24 | Howard Community Hospital at Howard Regional Health System | Kokomo | Indiana | United States | 46904 |
| 25 | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | United States | 46350 |
| 26 | Saint Anthony Memorial Health Centers | Michigan City | Indiana | United States | 46360 |
| 27 | CCOP - Northern Indiana CR Consortium | South Bend | Indiana | United States | 46601 |
| 28 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
| 29 | Saint Joseph Regional Medical Center | South Bend | Indiana | United States | 46617 |
| 30 | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | United States | 52242 |
| 31 | Union Hospital Cancer Program at Union Hospital | Elkton Md | Maryland | United States | 21921 |
| 32 | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | United States | 48106-0995 |
| 33 | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | United States | 48106 |
| 34 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
| 35 | Metro Health Hospital | Grand Rapids | Michigan | United States | 49503 |
| 36 | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | United States | 48236 |
| 37 | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | United States | 48073 |
| 38 | Seton Cancer Institute - Saginaw | Saginaw | Michigan | United States | 48601 |
| 39 | Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | St. Joseph | Michigan | United States | 49085 |
| 40 | St. John Macomb Hospital | Warren | Michigan | United States | 48093 |
| 41 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
| 42 | Saint Louis University Cancer Center | Saint Louis | Missouri | United States | 63110 |
| 43 | CCOP - Cancer Research for the Ozarks | Springfield | Missouri | United States | 65802 |
| 44 | St. John's Regional Health Center | Springfield | Missouri | United States | 65804 |
| 45 | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | United States | 65807 |
| 46 | Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri | United States | 63110 |
| 47 | Methodist Cancer Center at Methodist Hospital - Omaha | Omaha | Nebraska | United States | 68114 |
| 48 | UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-6805 |
| 49 | Women's Cancer Center - Las Vegas | Las Vegas | Nevada | United States | 89102 |
| 50 | Washoe Cancer Services at Washoe Medical Center - Reno | Reno | Nevada | United States | 89502 |
| 51 | Saint Mary's Regional Medical Center | Reno | Nevada | United States | 89503 |
| 52 | Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton | New Jersey | United States | 08053 |
| 53 | Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown | New Jersey | United States | 07962 |
| 54 | Overlook Hospital | Summit | New Jersey | United States | 07902 |
| 55 | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey | United States | 08043 |
| 56 | Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees | New Jersey | United States | 08043 |
| 57 | SUNY Downstate Medical Center | Brooklyn | New York | United States | 11203 |
| 58 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
| 59 | Good Samaritan Hospital Medical Center | West Islip | New York | United States | 11795 |
| 60 | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | United States | 28232-2861 |
| 61 | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | United States | 28233-3549 |
| 62 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
| 63 | Gynecologic Oncology Network | Greenville | North Carolina | United States | 27834 |
| 64 | Leo W. Jenkins Cancer Center at ECU Medical School | Greenville | North Carolina | United States | 27835-6028 |
| 65 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
| 66 | McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | United States | 44307 |
| 67 | Aultman Hospital Cancer Center at Aultman Health Foundation | Canton | Ohio | United States | 44710-1799 |
| 68 | Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | United States | 45267 |
| 69 | Case Comprehensive Cancer Center | Cleveland | Ohio | United States | 44106 |
| 70 | MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | United States | 44109 |
| 71 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
| 72 | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus | Ohio | United States | 43210-1240 |
| 73 | Riverside Methodist Hospital Cancer Care | Columbus | Ohio | United States | 43214-3998 |
| 74 | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
| 75 | Lake/University Ireland Cancer Center | Mentor | Ohio | United States | 44060 |
| 76 | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | United States | 73104 |
| 77 | Cancer Care Associates - Midtown Tulsa | Tulsa | Oklahoma | United States | 74104 |
| 78 | Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon | United States | 97213-2967 |
| 79 | Williamette Gynecologic Oncology PC | Portland | Oregon | United States | 97213 |
| 80 | Rosenfeld Cancer Center at Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
| 81 | Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | United States | 18105 |
| 82 | Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
| 83 | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104-4283 |
| 84 | Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | United States | 19111-2497 |
| 85 | Women and Infants Hospital of Rhode Island | Providence | Rhode Island | United States | 02905 |
| 86 | Rapid City Regional Hospital | Rapid City | South Dakota | United States | 57701 |
| 87 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
| 88 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0361 |
| 89 | CCOP - Scott and White Hospital | Temple | Texas | United States | 76508 |
| 90 | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | United States | 05401 |
| 91 | University of Virginia Cancer Center at UV Health System | Charlottesville | Virginia | United States | 22908 |
| 92 | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
| 93 | Carilion Gynecologic Oncology Associates | Roanoke | Virginia | United States | 24014 |
| 94 | Auburn Regional Center for Cancer Care | Auburn | Washington | United States | 98002 |
| 95 | Providence Centralia Hospital | Centralia | Washington | United States | 98531-9027 |
| 96 | St. Francis Hospital | Federal Way | Washington | United States | 98003 |
| 97 | Providence St. Peter Hospital Regional Cancer Center | Olympia | Washington | United States | 98506-5166 |
| 98 | Good Samaritan Cancer Center | Puyallup | Washington | United States | 98372 |
| 99 | St. Joseph Medical Center at Franciscan Health System | Tacoma | Washington | United States | 98405-3004 |
| 100 | Allenmore Hospital | Tacoma | Washington | United States | 98405 |
| 101 | CCOP - Northwest | Tacoma | Washington | United States | 98405 |
| 102 | MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma | Washington | United States | 98405 |
| 103 | St. Clare Hospital | Tacoma | Washington | United States | 98499 |
| 104 | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | United States | 54307-3508 |
| 105 | Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 106 | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | United States | 53792-6164 |
| 107 | Aurora Women's Pavilion of West Allis Memorial Hospital | West Allis | Wisconsin | United States | 53227 |
Sponsors and Collaborators
- Gynecologic Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Elise C. Kohn, MD, NCI - Medical Oncology Branch
- : Samir N. Khleif, MD, National Cancer Institute (NCI)
- : Larry J. Copeland, MD, Ohio State University Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00238342
Other Study ID Numbers:
- CDR0000445437
- GOG-0220
First Posted:
Oct 13, 2005
Last Update Posted:
Feb 9, 2010
Last Verified:
Apr 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: