YKL-40 in Serum Samples From Patients With Newly Diagnosed Stage III-IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer Receiving Chemotherapy

May 21, 2018 updated by: Gynecologic Oncology Group

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36688
        • University of South Alabama Mitchell Cancer Institute
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Saint Joseph's Hospital and Medical Center
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group PA - Fayetteville
    • California
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Beebe Medical Center
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System-Christiana Hospital
    • Florida
      • Orlando, Florida, United States, 32806
        • UF Cancer Center at Orlando Health
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Macon, Georgia, United States, 31201
        • Central Georgia Gynecologic Oncology
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
    • Illinois
      • Alton, Illinois, United States, 62002
        • Saint Anthony's Health
      • Hinsdale, Illinois, United States, 60521
        • Sudarshan K Sharma MD Limted-Gynecologic Oncology
      • Mount Vernon, Illinois, United States, 62864
        • Good Samaritan Regional Health Center
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Warrenville, Illinois, United States, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Health Indianapolis
      • Indianapolis, Indiana, United States, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46260
        • Saint Vincent Hospital and Health Care Center
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, United States, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50309
        • Iowa-Wide Oncology Research Coalition NCORP
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Kansas
      • Kansas City, Kansas, United States, 66112
        • Providence Medical Center
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Saint Elizabeth Medical Center South
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70817
        • Woman's Hospital
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center-Bramhall Campus
    • Maryland
      • Elkton, Maryland, United States, 21921
        • Union Hospital of Cecil County
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts Memorial Health Care
    • Michigan
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Hospital
      • Ann Arbor, Michigan, United States, 48106
        • Michigan Cancer Research Consortium NCORP
      • Dearborn, Michigan, United States, 48124
        • Beaumont Hospital-Dearborn
      • Detroit, Michigan, United States, 48236
        • Saint John Hospital and Medical Center
      • Flint, Michigan, United States, 48502
        • Hurley Medical Center
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, United States, 49503
        • Cancer Research Consortium of West Michigan NCORP
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49001
        • Borgess Medical Center
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
      • Livonia, Michigan, United States, 48154
        • Saint Mary Mercy Hospital
      • Muskegon, Michigan, United States, 49442
        • Mercy Health Partners-Hackley Campus
      • Pontiac, Michigan, United States, 48341
        • Saint Joseph Mercy Oakland
      • Port Huron, Michigan, United States, 48060
        • Lake Huron Medical Center
      • Saginaw, Michigan, United States, 48601
        • Saint Mary's of Michigan
      • Warren, Michigan, United States, 48093
        • Saint John Macomb-Oakland Hospital
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • Saint Louis, Missouri, United States, 63141
        • Saint Louis-Cape Girardeau CCOP
      • Springfield, Missouri, United States, 65804
        • Cancer Research for the Ozarks NCORP
      • Springfield, Missouri, United States, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Women's Cancer Center of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Brightwaters, New York, United States, 11718
        • Island Gynecologic Oncology
      • Fresh Meadows, New York, United States, 11365
        • New York Hospital Medical Center of Queens
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterian Medical Center
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
      • Wilmington, North Carolina, United States, 28401
        • New Hanover Regional Medical Center/Zimmer Cancer Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
      • Winston-Salem, North Carolina, United States, 27104
        • Southeast Clinical Oncology Research (SCOR) Consortium NCORP
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Akron City Hospital/Cooper Cancer Center
      • Akron, Ohio, United States, 44307
        • Akron General Medical Center
      • Canton, Ohio, United States, 44710
        • Aultman Health Foundation
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Paoli, Pennsylvania, United States, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
      • Wynnewood, Pennsylvania, United States, 19096
        • Main Line Health NCORP
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Cancer Center
      • Greenville, South Carolina, United States, 29601
        • Saint Francis Hospital
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Faris
      • Greenville, South Carolina, United States, 29605
        • Greenville Memorial Hospital
      • Greenville, South Carolina, United States, 29615
        • Greenville Health System Cancer Institute-Eastside
      • Greer, South Carolina, United States, 29651
        • Gibbs Cancer Center-Pelham
      • Seneca, South Carolina, United States, 29672
        • Greenville Health System Cancer Institute-Seneca
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
      • Spartanburg, South Carolina, United States, 29307
        • Greenville Health System Cancer Institute-Spartanburg
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Obstetrics and Gynecology
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Knoxville Gynecologic Cancer Specialists PC
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Amarillo, Texas, United States, 79106
        • The Don and Sybil Harrington Cancer Center
      • Fort Worth, Texas, United States, 76104
        • Baylor All Saints Medical Center at Fort Worth
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Eau Claire, Wisconsin, United States, 54701
        • Sacred Heart Hospital
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Marshfield, Wisconsin, United States, 54449
        • Saint Joseph's Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and The Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Clinic-Minocqua Center
      • Rhinelander, Wisconsin, United States, 54501
        • Marshfield Clinic at James Beck Cancer Center
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Clinic-Rice Lake Center
      • Stevens Point, Wisconsin, United States, 54481
        • Saint Michael's Hospital
      • Stevens Point, Wisconsin, United States, 54481
        • Marshfield Clinic Cancer Care at Saint Michael's Hospital
      • Wausau, Wisconsin, United States, 54401
        • Marshfield Clinic-Wausau Center
      • West Allis, Wisconsin, United States, 53227
        • Aurora West Allis Medical Center
      • Weston, Wisconsin, United States, 54476
        • Diagnostic and Treatment Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Marshfield Clinic - Wisconsin Rapids Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients With Newly Diagnosed Stage III-IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer Receiving Chemotherapy

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Cytology Specimen Collection Procedure
Correlative studies
Other Names:
  • Cytologic Sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CA125 measurements
Time Frame: 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.
Up to 10 years
Objective response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Time Frame: 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.
Up to 10 years
Time to disease progression using RECIST criteria
Time Frame: Up to 10 years
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)
Time Frame: 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.
From study entry until disease recurrence, death or date of last contact, assessed up to 10 years
YKL-40 measurements
Time Frame: 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.
Up to 10 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy response
Time Frame: Up to 10 years
As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting chemotherapy response will be described.
Up to 10 years
Optimal cut-off values for YKL-40
Time Frame: Up to 10 years
Optimal cut-off values for YKL-40 that subsequently can be used in clinical practice will be determined. Any statistical significance calculated for an optimized cut-off will adjust for the selection process, and any comparison with CA-125 will treat both markers in the same way.
Up to 10 years
Overall survival
Time Frame: From entry into the study to death or the date of last contact, assessed up to 10 years
As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting overall survival will be described.
From entry into the study to death or the date of last contact, assessed up to 10 years
Progression-free survival
Time Frame: From study entry until disease progression, death or date of last contact, assessed up to 10 years
As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting progression-free survival will be described.
From study entry until disease progression, death or date of last contact, assessed up to 10 years
Variability of CA125 measurements
Time Frame: Up to 10 years
Linear statistical methods, such as a random effects model, will be used to assess the variability and correlation of CA125 over time in this population.
Up to 10 years
Variability of YKL-40 measurements
Time Frame: Up to 10 years
Linear statistical methods, such as a random effects model, will be used to assess the variability and correlation of YKL-40 over time in this population.
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Katherine Bell-McGuinn, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 21, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-0235 (Other Identifier: CTEP)
  • U10CA180868 (U.S. NIH Grant/Contract)
  • U10CA027469 (U.S. NIH Grant/Contract)
  • NCI-2009-01083 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000540250

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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