YKL-40 in Serum Samples From Patients With Newly Diagnosed Stage III-IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer Receiving Chemotherapy
- Conditions
- Malignant Ovarian NeoplasmMalignant Ovarian Transitional Cell TumorStage IIIA Ovarian CancerFallopian Tube Endometrioid AdenocarcinomaFallopian Tube Serous AdenocarcinomaMalignant Ovarian Brenner TumorMalignant Ovarian Mixed Epithelial TumorFallopian Tube Clear Cell AdenocarcinomaMalignant Ovarian Mucinous TumorOvarian Adenocarcinoma
- Interventions
- Other: Cytology Specimen Collection ProcedureOther: Laboratory Biomarker Analysis
- Registration Number
- NCT00899093
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
This research trial studies chitinase 3-like 1 (cartilage glycoprotein-39) (YKL-40) in serum samples from patients with newly diagnosed stage III-IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer receiving chemotherapy. Studying samples of serum in the laboratory from patients receiving chemotherapy may help doctors learn more about the effects of chemotherapy on cells. It may also help doctors understand how well patients respond to treatment.
- Detailed Description
PRIMARY OBJECTIVES:
I. To assess the ability of the YKL-40 serum marker to detect response or lack of response to primary chemotherapy in International Federation of Gynecology and Obstetrics (FIGO) stage III or IV invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer.
II. To compare the predictive accuracy of YKL-40 with cancer antigen 125 (CA125).
SECONDARY OBJECTIVES:
I. To test the ability of the YKL-40 serum marker to detect recurrence of ovarian, primary peritoneal, or fallopian tube cancer in patients who are in first remission following primary chemotherapy.
II. To test the ability of the YKL-40 serum marker to predict poor risk patients with FIGO stage III or IV invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer.
TERTIARY OBJECTIVES:
I. To explore alternative cut-off values for YKL-40 elevation in this large patient population.
II. To describe the variability of YKL-40 and CA125 measurements in patients receiving primary chemotherapy and in primary remission in a large patient population.
III. To describe the accuracy of YKL-40 coupled with CA125 measurements in predicting chemotherapy response, progression-free survival and overall survival.
OUTLINE:
Patients undergo collection of serum samples for analysis of YKL-40 via enzyme-linked immunosorbent assay (ELISA) and CA125 via chemiluminometric sandwich immunoassay at the following time-points: at baseline; prior to beginning each course of chemotherapy (courses 1-6); at completion of chemotherapy; every 3 months during years 1-2 post-chemotherapy; every 6 months during years 3-5 post-chemotherapy; every year during years 6-10 post-chemotherapy; and at time of disease recurrence or progression.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 2500
- Patients with a histologic diagnosis of FIGO stage III or IV invasive epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who will receive primary chemotherapy for newly diagnosed disease; eligible histologic cell types include serous, mucinous, endometrioid, clear cell, transitional, mixed epithelial, undifferentiated, adenocarcinoma, not otherwise specified (NOS) and malignant Brenner tumor
- Patients who have undergone full surgical staging as described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual
- Patients who have met the pre-entry requirements
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
- The following histologic cell types are not eligible: carcinosarcoma (malignant mixed Mullerian tumor) and borderline epithelial tumors (low malignant potential, atypical proliferative)
- Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian cancer treated with surgery only (such as those with stage IA or IB low grade lesions) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
- Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than IB; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions
- With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy are excluded
- Patients who receive neoadjuvant chemotherapy prior to surgical staging
- Individuals with a diagnosis of rheumatoid arthritis, severe uncontrolled osteoarthritis, hepatic fibrosis or other active chronic inflammatory condition
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ancillary-Correlative (serum collection for YKL-40 and CA125) Cytology Specimen Collection Procedure Patients undergo collection of serum samples for analysis of YKL-40 via ELISA and CA125 via chemiluminometric sandwich immunoassay at the following time-points: at baseline; prior to beginning each course of chemotherapy (courses 1-6); at completion of chemotherapy; every 3 months during years 1-2 post-chemotherapy; every 6 months during years 3-5 post-chemotherapy; every year during years 6-10 post-chemotherapy; and at time of disease recurrence or progression. Ancillary-Correlative (serum collection for YKL-40 and CA125) Laboratory Biomarker Analysis Patients undergo collection of serum samples for analysis of YKL-40 via ELISA and CA125 via chemiluminometric sandwich immunoassay at the following time-points: at baseline; prior to beginning each course of chemotherapy (courses 1-6); at completion of chemotherapy; every 3 months during years 1-2 post-chemotherapy; every 6 months during years 3-5 post-chemotherapy; every year during years 6-10 post-chemotherapy; and at time of disease recurrence or progression.
- Primary Outcome Measures
Name Time Method Time to tumor recurrence (relapse) From study entry until disease recurrence, death or date of last contact, assessed up to 10 years Parallel analyses of the markers as predictors of time-to-relapse will be performed using survival-type regression methods such as the Cox proportional hazards model or a parametric maximum likelihood model. The total number of patients available for analysis of time to relapse is the number of patients who respond to treatment.
YKL-40 measurements Up to 10 years YKL-40 will be compared to CA125 in terms of its ability to detect response to chemotherapy (during chemotherapy) and recurrence of disease (in remission). Serum YKL-40 behavior will also be assessed as a reflection of tumor histology, tumor grade, and tumor stage-all in comparison to CA125. The accuracy of each marker alone will be compared using area under the receiver operating characteristic (ROC) curve, and assess which adds more predictive information when both are included in logistic regression.
CA125 measurements Up to 10 years The accuracy of each marker alone will be compared using area under the ROC curve, and assess which adds more predictive information when both are included in logistic regression.
Objective response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria Up to 10 years In order to make a valid comparison between CA125 and YKL-40, in this study computed tomography (CT) criteria will be treated as the "gold standard" and whether changes in YKL-40 levels correlate with CT evidence as well as or better than changes in CA125 levels will be evaluated.
Time to disease progression using RECIST criteria Up to 10 years Parallel statistical analyses of time to disease progression will also be conducted for patients who do not respond.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (131)
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Central Georgia Gynecologic Oncology
🇺🇸Macon, Georgia, United States
Smilow Cancer Hospital Care Center at Saint Francis
🇺🇸Hartford, Connecticut, United States
Highlands Oncology Group PA - Fayetteville
🇺🇸Fayetteville, Arkansas, United States
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States
CoxHealth South Hospital
🇺🇸Springfield, Missouri, United States
The Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
Saint Mary's of Michigan
🇺🇸Saginaw, Michigan, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Saint Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Saint John Macomb-Oakland Hospital
🇺🇸Warren, Michigan, United States
Mercy Health Partners-Hackley Campus
🇺🇸Muskegon, Michigan, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Mercy Hospital Saint Louis
🇺🇸Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
New York Hospital Medical Center of Queens
🇺🇸Fresh Meadows, New York, United States
Main Line Health NCORP
🇺🇸Wynnewood, Pennsylvania, United States
Lake Huron Medical Center
🇺🇸Port Huron, Michigan, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
🇺🇸Wilmington, North Carolina, United States
Island Gynecologic Oncology
🇺🇸Brightwaters, New York, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
🇺🇸Tulsa, Oklahoma, United States
Saint Francis Hospital
🇺🇸Greenville, South Carolina, United States
Knoxville Gynecologic Cancer Specialists PC
🇺🇸Knoxville, Tennessee, United States
Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Greenville Health System Cancer Institute-Seneca
🇺🇸Seneca, South Carolina, United States
Aultman Health Foundation
🇺🇸Canton, Ohio, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Marshfield Clinic-Wausau Center
🇺🇸Wausau, Wisconsin, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Reading Hospital
🇺🇸West Reading, Pennsylvania, United States
Marshfield Clinic at James Beck Cancer Center
🇺🇸Rhinelander, Wisconsin, United States
Marshfield Clinic-Minocqua Center
🇺🇸Minocqua, Wisconsin, United States
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
Aurora West Allis Medical Center
🇺🇸West Allis, Wisconsin, United States
Diagnostic and Treatment Center
🇺🇸Weston, Wisconsin, United States
Sacred Heart Hospital
🇺🇸Eau Claire, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
🇺🇸Wisconsin Rapids, Wisconsin, United States
Marshfield Clinic-Rice Lake Center
🇺🇸Rice Lake, Wisconsin, United States
Saint Joseph's Hospital
🇺🇸Marshfield, Wisconsin, United States
Marshfield Clinic - Weston Center
🇺🇸Weston, Wisconsin, United States
Indiana University/Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center
🇺🇸Indianapolis, Indiana, United States
Franciscan Health Indianapolis
🇺🇸Indianapolis, Indiana, United States
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Good Samaritan Hospital - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University/Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Saint Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Saint John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Saint Louis-Cape Girardeau CCOP
🇺🇸Saint Louis, Missouri, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
University of South Alabama Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
🇺🇸Burbank, California, United States
Saint Alphonsus Cancer Care Center-Boise
🇺🇸Boise, Idaho, United States
Saint Anthony's Health
🇺🇸Alton, Illinois, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology
🇺🇸Hinsdale, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
🇺🇸Warrenville, Illinois, United States
University of Iowa/Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Saint Elizabeth Medical Center South
🇺🇸Edgewood, Kentucky, United States
Providence Medical Center
🇺🇸Kansas City, Kansas, United States
Woman's Hospital
🇺🇸Baton Rouge, Louisiana, United States
Union Hospital of Cecil County
🇺🇸Elkton, Maryland, United States
Maine Medical Center-Bramhall Campus
🇺🇸Portland, Maine, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Beaumont Hospital-Dearborn
🇺🇸Dearborn, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Cancer Research Consortium of West Michigan NCORP
🇺🇸Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Allegiance Health
🇺🇸Jackson, Michigan, United States
Saint Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Sparrow Hospital
🇺🇸Lansing, Michigan, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
AnMed Health Cancer Center
🇺🇸Anderson, South Carolina, United States
Black Hills Obstetrics and Gynecology
🇺🇸Rapid City, South Dakota, United States
Women and Infants Hospital
🇺🇸Providence, Rhode Island, United States
The Don and Sybil Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Marshfield Clinic Cancer Center at Sacred Heart
🇺🇸Eau Claire, Wisconsin, United States
Marshfield Clinic Cancer Care at Saint Michael's Hospital
🇺🇸Stevens Point, Wisconsin, United States
Saint Michael's Hospital
🇺🇸Stevens Point, Wisconsin, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
University of Massachusetts Memorial Health Care
🇺🇸Worcester, Massachusetts, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Froedtert and the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Christiana Care Health System-Christiana Hospital
🇺🇸Newark, Delaware, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Novant Health Presbyterian Medical Center
🇺🇸Charlotte, North Carolina, United States
Cancer Research for the Ozarks NCORP
🇺🇸Springfield, Missouri, United States
Summa Akron City Hospital/Cooper Cancer Center
🇺🇸Akron, Ohio, United States
Greenville Health System Cancer Institute-Faris
🇺🇸Greenville, South Carolina, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
🇺🇸Greenville, South Carolina, United States
Gibbs Cancer Center-Pelham
🇺🇸Greer, South Carolina, United States
Spartanburg Medical Center
🇺🇸Spartanburg, South Carolina, United States
Aurora BayCare Medical Center
🇺🇸Green Bay, Wisconsin, United States
Baylor All Saints Medical Center at Fort Worth
🇺🇸Fort Worth, Texas, United States
Greenville Health System Cancer Institute-Spartanburg
🇺🇸Spartanburg, South Carolina, United States
UF Cancer Center at Orlando Health
🇺🇸Orlando, Florida, United States
Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
🇺🇸Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Saint Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium NCORP
🇺🇸Ann Arbor, Michigan, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States