YKL-40 in Serum Samples From Patients With Newly Diagnosed Stage III-IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer Receiving Chemotherapy
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
5 other identifiers
observational
2,500
1 country
131
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
131 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 9, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedMay 22, 2018
May 1, 2018
8.8 years
May 9, 2009
May 21, 2018
Conditions
Outcome Measures
Primary Outcomes (5)
CA125 measurements
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.
Up to 10 years
Objective response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria
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.
Up to 10 years
Time to disease progression using RECIST criteria
Parallel statistical analyses of time to disease progression will also be conducted for patients who do not respond.
Up to 10 years
Time to tumor recurrence (relapse)
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.
From study entry until disease recurrence, death or date of last contact, assessed up to 10 years
YKL-40 measurements
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.
Up to 10 years
Other Outcomes (6)
Chemotherapy response
Up to 10 years
Optimal cut-off values for YKL-40
Up to 10 years
Overall survival
From entry into the study to death or the date of last contact, assessed up to 10 years
- +3 more other outcomes
Study Arms (1)
Ancillary-Correlative (serum collection for YKL-40 and CA125)
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.
Interventions
Correlative studies
Correlative studies
Eligibility Criteria
Patients With Newly Diagnosed Stage III-IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer Receiving Chemotherapy
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (131)
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36688, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Highlands Oncology Group PA - Fayetteville
Fayetteville, Arkansas, 72703, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
UF Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Central Georgia Gynecologic Oncology
Macon, Georgia, 31201, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Anthony's Health
Alton, Illinois, 62002, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, 60521, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Providence Medical Center
Kansas City, Kansas, 66112, United States
Saint Elizabeth Medical Center South
Edgewood, Kentucky, 41017, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Woman's Hospital
Baton Rouge, Louisiana, 70817, United States
Maine Medical Center-Bramhall Campus
Portland, Maine, 04102, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, 01605, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, 48124, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Mercy Health Partners-Hackley Campus
Muskegon, Michigan, 49442, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, 65804, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Island Gynecologic Oncology
Brightwaters, New York, 11718, United States
New York Hospital Medical Center of Queens
Fresh Meadows, New York, 11365, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina, 28401, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, 27104, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Main Line Health NCORP
Wynnewood, Pennsylvania, 19096, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, 29307, United States
Black Hills Obstetrics and Gynecology
Rapid City, South Dakota, 57701, United States
Knoxville Gynecologic Cancer Specialists PC
Knoxville, Tennessee, 37920, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106, United States
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, 76104, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701, United States
Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, 54449, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, 54501, United States
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, 54868, United States
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Diagnostic and Treatment Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Bell-McGuinn
NRG Oncology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2009
First Posted
May 12, 2009
Study Start
September 1, 2007
Primary Completion
June 1, 2016
Last Updated
May 22, 2018
Record last verified: 2018-05