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

• Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Gynecologic Oncology Group

Study Description

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.

Condition or disease

Intervention/treatment

Fallopian Tube Adenocarcinoma; Fallopian Tube Clear Cell Adenocarcinoma; Fallopian Tube Endometrioid Adenocarcinoma; Fallopian Tube Mucinous Adenocarcinoma; Fallopian Tube Serous Adenocarcinoma; Fallopian Tube Transitional Cell Carcinoma; Malignant Ovarian Brenner Tumor; Malignant Ovarian Clear Cell Tumor; Malignant Ovarian Endometrioid Tumor; Malignant Ovarian Mixed Epithelial Tumor; Malignant Ovarian Mucinous Tumor; Malignant Ovarian Neoplasm; Malignant Ovarian Serous Tumor; Malignant Ovarian Transitional Cell Tumor; Ovarian Adenocarcinoma; Primary Peritoneal Serous Adenocarcinoma; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Cancer; Stage IIIA Primary Peritoneal Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Cancer; Stage IIIB Primary Peritoneal Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Cancer; Stage IIIC Primary Peritoneal Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Cancer; Stage IV Primary Peritoneal Cancer; Undifferentiated Fallopian Tube Carcinoma; Undifferentiated Ovarian Carcinoma

Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

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 Design

• Study Type: Observational
• Estimated Enrollment: 2500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Study Start Date: September 2007
• Actual Primary Completion Date: June 2016

Groups and Cohorts

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: Cytology Specimen Collection Procedure; Correlative studies; Other Name: Cytologic Sampling; Other: Laboratory Biomarker Analysis; Correlative studies

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

Other Outcome Measures:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• 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

Criteria

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

Contacts and Locations

  Hide Study Locations

Locations

United States, Alabama

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States, 36688

United States, Arizona

Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, United States, 85013

United States, Arkansas

Highlands Oncology Group PA - Fayetteville

Fayetteville, Arkansas, United States, 72703

United States, California

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States, 91505

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States, 92868

United States, Connecticut

Hartford Hospital

Hartford, Connecticut, United States, 06102

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States, 06105

The Hospital of Central Connecticut

New Britain, Connecticut, United States, 06050

United States, Delaware

Beebe Medical Center

Lewes, Delaware, United States, 19958

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States, 19718

United States, Florida

UF Cancer Center at Orlando Health

Orlando, Florida, United States, 32806

United States, Georgia

Northside Hospital

Atlanta, Georgia, United States, 30342

Central Georgia Gynecologic Oncology

Macon, Georgia, United States, 31201

United States, Idaho

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States, 83706

United States, Illinois

Saint Anthony's Health

Alton, Illinois, United States, 62002

Sudarshan K Sharma MD Limted-Gynecologic Oncology

Hinsdale, Illinois, United States, 60521

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States, 62864

Carle Cancer Center

Urbana, Illinois, United States, 61801

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States, 60555

United States, Indiana

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States, 46202

Franciscan Health Indianapolis

Indianapolis, Indiana, United States, 46237

Saint Vincent Hospital and Health Care Center

Indianapolis, Indiana, United States, 46260

United States, Iowa

Iowa Methodist Medical Center

Des Moines, Iowa, United States, 50309

Iowa-Wide Oncology Research Coalition NCORP

Des Moines, Iowa, United States, 50309

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States, 50309

Medical Oncology and Hematology Associates-Laurel

Des Moines, Iowa, United States, 50314

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States, 50314

Iowa Lutheran Hospital

Des Moines, Iowa, United States, 50316

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States, 52242

United States, Kansas

Providence Medical Center

Kansas City, Kansas, United States, 66112

United States, Kentucky

Saint Elizabeth Medical Center South

Edgewood, Kentucky, United States, 41017

Baptist Health Lexington

Lexington, Kentucky, United States, 40503

United States, Louisiana

Woman's Hospital

Baton Rouge, Louisiana, United States, 70817

United States, Maine

Maine Medical Center-Bramhall Campus

Portland, Maine, United States, 04102

United States, Maryland

Union Hospital of Cecil County

Elkton, Maryland, United States, 21921

United States, Massachusetts

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

University of Massachusetts Memorial Health Care

Worcester, Massachusetts, United States, 01605

United States, Michigan

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States, 48106-0995

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, United States, 48106

Beaumont Hospital-Dearborn

Dearborn, Michigan, United States, 48124

Saint John Hospital and Medical Center

Detroit, Michigan, United States, 48236

Hurley Medical Center

Flint, Michigan, United States, 48502

Genesys Regional Medical Center

Grand Blanc, Michigan, United States, 48439

Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, United States, 49503

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States, 49503

Allegiance Health

Jackson, Michigan, United States, 49201

Borgess Medical Center

Kalamazoo, Michigan, United States, 49001

Bronson Methodist Hospital

Kalamazoo, Michigan, United States, 49007

West Michigan Cancer Center

Kalamazoo, Michigan, United States, 49007

Sparrow Hospital

Lansing, Michigan, United States, 48912

Saint Mary Mercy Hospital

Livonia, Michigan, United States, 48154

Mercy Health Partners-Hackley Campus

Muskegon, Michigan, United States, 49442

Saint Joseph Mercy Oakland

Pontiac, Michigan, United States, 48341

Lake Huron Medical Center

Port Huron, Michigan, United States, 48060

Saint Mary's of Michigan

Saginaw, Michigan, United States, 48601

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States, 48093

United States, Mississippi

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

United States, Missouri

Saint Francis Medical Center

Cape Girardeau, Missouri, United States, 63703

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States, 64111

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

Mercy Hospital Saint Louis

Saint Louis, Missouri, United States, 63141

Saint Louis-Cape Girardeau CCOP

Saint Louis, Missouri, United States, 63141

Cancer Research for the Ozarks NCORP

Springfield, Missouri, United States, 65804

Mercy Hospital Springfield

Springfield, Missouri, United States, 65804

CoxHealth South Hospital

Springfield, Missouri, United States, 65807

United States, Montana

Billings Clinic Cancer Center

Billings, Montana, United States, 59101

United States, Nebraska

Nebraska Methodist Hospital

Omaha, Nebraska, United States, 68114

United States, Nevada

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States, 89169

United States, New Hampshire

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

United States, New Jersey

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08903

United States, New York

Island Gynecologic Oncology

Brightwaters, New York, United States, 11718

New York Hospital Medical Center of Queens

Fresh Meadows, New York, United States, 11365

Winthrop University Hospital

Mineola, New York, United States, 11501

Memorial Sloan-Kettering Cancer Center

New York, New York, United States, 10065

Stony Brook University Medical Center

Stony Brook, New York, United States, 11794

State University of New York Upstate Medical University

Syracuse, New York, United States, 13210

United States, North Carolina

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States, 28204

Rutherford Hospital

Rutherfordton, North Carolina, United States, 28139

New Hanover Regional Medical Center/Zimmer Cancer Center

Wilmington, North Carolina, United States, 28401

Southeast Clinical Oncology Research (SCOR) Consortium NCORP

Winston-Salem, North Carolina, United States, 27104

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

Summa Akron City Hospital/Cooper Cancer Center

Akron, Ohio, United States, 44304

Akron General Medical Center

Akron, Ohio, United States, 44307

Aultman Health Foundation

Canton, Ohio, United States, 44710

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, United States, 45220

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Riverside Methodist Hospital

Columbus, Ohio, United States, 43214

Miami Valley Hospital

Dayton, Ohio, United States, 45409

United States, Oklahoma

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, United States, 74146

United States, Pennsylvania

Abington Memorial Hospital

Abington, Pennsylvania, United States, 19001

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States, 19010

Paoli Memorial Hospital

Paoli, Pennsylvania, United States, 19301

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Reading Hospital

West Reading, Pennsylvania, United States, 19611

Lankenau Medical Center

Wynnewood, Pennsylvania, United States, 19096

Main Line Health NCORP

Wynnewood, Pennsylvania, United States, 19096

United States, Rhode Island

Women and Infants Hospital

Providence, Rhode Island, United States, 02905

United States, South Carolina

AnMed Health Cancer Center

Anderson, South Carolina, United States, 29621

Saint Francis Hospital

Greenville, South Carolina, United States, 29601

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, United States, 29605

Greenville Memorial Hospital

Greenville, South Carolina, United States, 29605

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, United States, 29615

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States, 29651

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, United States, 29672

Spartanburg Medical Center

Spartanburg, South Carolina, United States, 29303

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, United States, 29307

United States, South Dakota

Black Hills Obstetrics and Gynecology

Rapid City, South Dakota, United States, 57701

United States, Tennessee

Knoxville Gynecologic Cancer Specialists PC

Knoxville, Tennessee, United States, 37920

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States, 37232

United States, Texas

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, United States, 79106

Baylor All Saints Medical Center at Fort Worth

Fort Worth, Texas, United States, 76104

United States, Virginia

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States, 23298

United States, Wisconsin

Marshfield Clinic Cancer Center at Sacred Heart

Eau Claire, Wisconsin, United States, 54701

Sacred Heart Hospital

Eau Claire, Wisconsin, United States, 54701

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States, 54311

Marshfield Clinic

Marshfield, Wisconsin, United States, 54449

Saint Joseph's Hospital

Marshfield, Wisconsin, United States, 54449

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States, 53215

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, United States, 54548

Marshfield Clinic at James Beck Cancer Center

Rhinelander, Wisconsin, United States, 54501

Marshfield Clinic-Rice Lake Center

Rice Lake, Wisconsin, United States, 54868

Marshfield Clinic Cancer Care at Saint Michael's Hospital

Stevens Point, Wisconsin, United States, 54481

Saint Michael's Hospital

Stevens Point, Wisconsin, United States, 54481

Marshfield Clinic-Wausau Center

Wausau, Wisconsin, United States, 54401

Aurora West Allis Medical Center

West Allis, Wisconsin, United States, 53227

Diagnostic and Treatment Center

Weston, Wisconsin, United States, 54476

Marshfield Clinic - Weston Center

Weston, Wisconsin, United States, 54476

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, United States, 54494

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Katherine Bell-McGuinn; NRG Oncology

More Information

• Responsible Party: Gynecologic Oncology Group
• ClinicalTrials.gov Identifier: NCT00899093 History of Changes
• Other Study ID Numbers: GOG-0235; NCI-2009-01083 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); CDR0000540250; GOG-0235 ( Other Identifier: NRG Oncology ); GOG-0235 ( Other Identifier: CTEP ); U10CA180868 ( U.S. NIH Grant/Contract ); U10CA027469 ( U.S. NIH Grant/Contract )
• First Posted: May 12, 2009
• Last Update Posted: May 22, 2018
• Last Verified: May 2018

Additional relevant MeSH terms:

Carcinoma; Neoplasms; Adenocarcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Transitional Cell; Carcinoma, Endometrioid; Cystadenocarcinoma, Serous; Adenocarcinoma, Mucinous; Cystadenocarcinoma; Adenocarcinoma, Clear Cell; Brenner Tumor; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases