Tumor Marker YKL-40 in Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Undergoing Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00899093
First received: May 9, 2009
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

This laboratory study is assessing tumor marker YKL-40 in patients with newly diagnosed stage III or stage IV ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer undergoing chemotherapy. A study that assesses the tumor marker YKL-40 may help doctors learn how patients respond to treatment.


Condition Intervention
Brenner Tumor
Fallopian Tube Cancer
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Primary Peritoneal Cavity Cancer
Stage III Ovarian Epithelial Cancer
Stage IV Ovarian Epithelial Cancer
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Objective response as measured by RECIST criteria [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: September 2007
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-Correlative (blood collection)
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.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.

II. Compare the predictive accuracy of YKL-40 vs CA-125, in terms of disease response to chemotherapy and relapse, in these patients.

SECONDARY OBJECTIVES:

I. 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.

II. Assess the ability of YKL-40 to predict poor outcome in these patients.

TERTIARY OBJECTIVES:

I. Determine alternative cutoff values for YKL-40 elevation in these patients. II. Determine the variability of YKL-40 and CA-125 measurements in patients receiving primary chemotherapy and in patients in primary remission.

III. Determine the accuracy of YKL-40 coupled with CA-125 measurements in predicting chemotherapy response, progression-free survival, and overall survival of these patients.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a histologic diagnosis of FIGO stage III or IV invasive epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that will undergo full surgical staging according to the GOG Surgical Procedures Manual and will receive primary chemotherapy for newly diagnosed disease

Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of 1 of the following:

    • Invasive ovarian epithelial cancer
    • Primary peritoneal cavity cancer
    • Fallopian tube cancer
  • Federation of Gynecology and Obstetrics (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 cancer
  • No rheumatoid arthritis, severe uncontrolled osteoarthritis, hepatic fibrosis, or other active chronic inflammatory condition
  • No neoadjuvant chemotherapy prior to surgical staging
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899093

  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
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Saint Francis Hospital and Medical Center
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
Cadence Cancer Center in Warrenville
Warrenville, Illinois, United States, 60555
United States, Indiana
Saint Vincent Oncology Center
Indianapolis, Indiana, United States, 46260
Gynecologic Oncology of Indiana
Indianapolis, Indiana, United States, 46237
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Franciscan Saint Francis Health-Indianapolis
Indianapolis, Indiana, United States, 46237
United States, Iowa
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics
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 MD, 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 Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital and Medical Center
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
Gynecologic Oncology of West Michigan PLLC
Grand Rapids, Michigan, United States, 49546
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Allegiance Health
Jackson, Michigan, United States, 49201
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
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, 48341-2985
Saint Joseph Mercy Port Huron
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 Cancer Institute
Kansas City, Missouri, United States, 64111
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Saint Louis-Cape Girardeau CCOP
Saint Louis, Missouri, United States, 63141
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65804
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
United States, Montana
Billings Clinic
Billings, Montana, United States, 59107-7000
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
Wilmington, North Carolina, United States, 28401
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
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
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute
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
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Mainline Health CCOP
Wynnewood, Pennsylvania, United States, 19096
Lankenau Hospital
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
Greenville Health System Cancer Institute/Greenville CCOP
Greenville, South Carolina, United States, 29615
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
Upstate Carolina CCOP
Spartanburg, South Carolina, United States, 29303
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
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-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
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555-0565
United States, Virginia
Virginia Commonwealth University
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, 54311-6519
Saint Joseph's Hospital
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic
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
Investigators
Principal Investigator: Katherine Bell-McGuinn Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00899093     History of Changes
Other Study ID Numbers: GOG-0235, NCI-2009-01083, CDR0000540250, GOG-0235, GOG-0235, GOG-0235, U10CA027469
Study First Received: May 9, 2009
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Brenner Tumor
Carcinoma
Carcinoma, Endometrioid
Cystadenocarcinoma
Cystadenocarcinoma, Mucinous
Cystadenocarcinoma, Serous
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Endometrial Neoplasms
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue

ClinicalTrials.gov processed this record on October 20, 2014