A Prospective, Longitudinal Study of YKL-40 in Patients With FIGO Stage III or IV Invasive Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Undergoing Primary Chemotherapy
OBJECTIVES:
Primary
- Assess the ability of the serum marker, YKL-40, to detect response or lack of response
to primary chemotherapy in patients with newly diagnosed stage III or IV invasive
ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.
- Compare the predictive accuracy of YKL-40 vs CA-125, in terms of disease response to
chemotherapy and relapse, in these patients.
Secondary
- Assess the ability of YKL-40 to detect recurrence of ovarian epithelial, primary
peritoneal cavity, or fallopian tube cancer in patients who are in first remission
after primary chemotherapy.
- Assess the ability of YKL-40 to predict poor outcome in these patients.
- Determine alternative cutoff values for YKL-40 elevation in these patients.
- Determine the variability of YKL-40 and CA-125 measurements in patients receiving
primary chemotherapy and in patients in primary remission.
- Determine the accuracy of YKL-40 coupled with CA-125 measurements in predicting
chemotherapy response, progression-free survival, and overall survival of these
patients.
OUTLINE: This is a prospective, longitudinal study.
Patients undergo blood collection at baseline and then periodically thereafter for
evaluation of tumor marker YKL-40. Serum values for YKL-40 are compared with those of
another tumor marker, CA-125, to assess the sensitivity and specificity of YKL-40 in
detecting early-stage cancer, response to treatment, and disease relapse.
Patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: A total of 2,500 patients will be accrued for this study.
Observational
N/A
Objective response as measured by RECIST criteria
No
Carol Aghajanian, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
Unspecified
CDR0000540250
NCT00899093
September 2007
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
Aultman Cancer Center at Aultman Hospital | Canton, Ohio 44710-1799 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee, Wisconsin 53201-2901 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Winthrop University Hospital | Mineola, New York 11501 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
St. Elizabeth Medical Center | Edgewood, Kentucky 41017 |
Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
University of South Alabama Mitchell Cancer Institute | Mobile, Alabama 36604 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Gynecologic Oncology of Indiana | Indianapolis, Indiana 46237 |
Maine Medical Center - Bramhall Campus | Portland, Maine 04102 |
Cancer Care Associates - Saint Francis Campus | Tulsa, Oklahoma 74136-1929 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire, Wisconsin 54701 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center | Green Bay, Wisconsin 54311 |
Saint Joseph's Hospital | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
Vince Lombardi Cancer Clinic - Sheboygan | Sheboygan, Wisconsin 53081 |
Marshfield Clinic at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Saint Michael's Hospital Cancer Center | Stevens Point, Wisconsin 54481 |
Marshfield Clinic - Wausau Center | Wausau, Wisconsin 54401 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Woman's Hospital | Baton Rouge, Louisiana 70815 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Women's Cancer Center - La Canada | Las Vegas, Nevada 89169 |
Good Samaritan Hospital Cancer Treatment Center | Cincinnati, Ohio 45220 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
CCOP - Main Line Health | Wynnewood, Pennsylvania 19096 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
Central Georgia Gynecologic Oncology | Macon, Georgia 31201 |
Gynecologic Oncology of West Michigan | Grand Rapids, Michigan 49546 |
Black Hills Obstetrics & Gynecology LLP | Rapid City, South Dakota 57701 |
Aurora Women's Pavilion of West Allis Memorial Hospital | West Allis, Wisconsin 53227 |
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | Burbank, California 91505 |
Central Dupage Cancer Center | Warrenville, Illinois 60555 |
All Saints Episcopal Hospital - Fort Worth | Fort Worth, Texas 76104 |