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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

18 Years
Open (Enrolling)
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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



- 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.


- 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

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.

Inclusion Criteria


- Histologically confirmed diagnosis of 1 of the following:

- Invasive ovarian epithelial cancer

- Primary peritoneal cavity cancer

- Fallopian tube cancer

- FIGO stage III or IV disease

- The following histologic cell types are allowed:

- Serous adenocarcinoma

- Mucinous adenocarcinoma

- Endometrioid adenocarcinoma

- Clear cell adenocarcinoma

- Transitional cell carcinoma

- Mixed epithelial carcinoma

- Undifferentiated carcinoma

- Adenocarcinoma not otherwise specified

- Malignant Brenner tumor

- The following histologic cell types are not allowed:

- Carcinosarcoma (i.e., malignant mixed Müllerian tumor)

- Borderline epithelial tumors (i.e., low malignant potential or atypical
proliferative tumors)

- Patients with a prior diagnosis of a borderline tumor that was surgically
resected who subsequently develop an unrelated, new, invasive ovarian
epithelial or peritoneal primary cancer are eligible provided patient
received no prior chemotherapy for any ovarian tumor

- Newly diagnosed disease AND planning to receive primary chemotherapy

- Has undergone full surgical staging

- No recurrent invasive ovarian epithelial cancer treated with surgery only (e.g.,
stage IA or IB low-grade lesions)

- No synchronous primary endometrial cancer or prior endometrial cancer unless all of
the following criteria are met:

- Stage IA or IB disease

- Superficial myometrial invasion without vascular or lymphatic invasion

- No poorly differentiated subtypes (e.g., papillary serous, clear cell, or other
FIGO grade 3 lesions)


- No other invasive malignancies within the past 5 years except for nonmelanoma skin

- No rheumatoid arthritis, severe uncontrolled osteoarthritis, hepatic fibrosis, or
other active chronic inflammatory condition


- See Disease Characteristics

- More than 3 years since prior adjuvant chemotherapy for localized breast cancer AND
no recurrent or metastatic disease

- No prior cancer treatment that contraindicates study therapy

- No prior chemotherapy for any abdominal or pelvic tumor

- No neoadjuvant chemotherapy prior to surgical staging

Type of Study:


Study Design:


Outcome Measure:

Objective response as measured by RECIST criteria

Safety Issue:


Principal Investigator

Carol Aghajanian, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center



Study ID:




Start Date:

September 2007

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • ovarian mixed epithelial carcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian undifferentiated adenocarcinoma
  • Brenner tumor
  • stage IIIA primary peritoneal cavity cancer
  • stage IIIB primary peritoneal cavity cancer
  • stage IIIC primary peritoneal cavity cancer
  • stage IV primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



Memorial Sloan-Kettering Cancer Center New York, New York  10021
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Hurley Medical Center Flint, Michigan  48503
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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
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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
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Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
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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
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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
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Cancer Centers of the Carolinas - Spartanburg Spartanburg, South Carolina  29307
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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