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

Stage IV Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00899093
• Other study ID #: GOG-0235
• Secondary ID: NCI-2009-01083CD
• Status: Terminated
• Start date: September 2007

Study information

• Verified date: May 2018
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 2500
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma, Mucinous
• Brenner Tumor
• Carcinoma
• Carcinoma, Endometrioid
• Carcinoma, Transitional Cell
• Cystadenocarcinoma
• Fallopian Tube Adenocarcinoma
• Fallopian Tube Clear Cell Adenocarcinoma
• Fallopian Tube Endometrioid Adenocarcinoma
• Fallopian Tube Mucinous Adenocarcinoma
• Fallopian Tube Neoplasms
• 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
• Neoplasms
• Ovarian Adenocarcinoma
• Ovarian Neoplasms
• Peritoneal Neoplasms
• 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

Intervention

Other:
• Cytology Specimen Collection Procedure
Correlative studies
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Akron General Medical Center	Akron	Ohio
United States	Summa Akron City Hospital/Cooper Cancer Center	Akron	Ohio
United States	Saint Anthony's Health	Alton	Illinois
United States	The Don and Sybil Harrington Cancer Center	Amarillo	Texas
United States	AnMed Health Cancer Center	Anderson	South Carolina
United States	Michigan Cancer Research Consortium NCORP	Ann Arbor	Michigan
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Northside Hospital	Atlanta	Georgia
United States	Woman's Hospital	Baton Rouge	Louisiana
United States	Billings Clinic Cancer Center	Billings	Montana
United States	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho
United States	Island Gynecologic Oncology	Brightwaters	New York
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Providence Saint Joseph Medical Center/Disney Family Cancer Center	Burbank	California
United States	Aultman Health Foundation	Canton	Ohio
United States	Saint Francis Medical Center	Cape Girardeau	Missouri
United States	Novant Health Presbyterian Medical Center	Charlotte	North Carolina
United States	Good Samaritan Hospital - Cincinnati	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Miami Valley Hospital	Dayton	Ohio
United States	Beaumont Hospital-Dearborn	Dearborn	Michigan
United States	Iowa Lutheran Hospital	Des Moines	Iowa
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	Saint John Hospital and Medical Center	Detroit	Michigan
United States	Marshfield Clinic Cancer Center at Sacred Heart	Eau Claire	Wisconsin
United States	Sacred Heart Hospital	Eau Claire	Wisconsin
United States	Saint Elizabeth Medical Center South	Edgewood	Kentucky
United States	Union Hospital of Cecil County	Elkton	Maryland
United States	Highlands Oncology Group PA - Fayetteville	Fayetteville	Arkansas
United States	Hurley Medical Center	Flint	Michigan
United States	Baylor All Saints Medical Center at Fort Worth	Fort Worth	Texas
United States	New York Hospital Medical Center of Queens	Fresh Meadows	New York
United States	Genesys Regional Medical Center	Grand Blanc	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	Aurora BayCare Medical Center	Green Bay	Wisconsin
United States	Greenville Health System Cancer Institute-Eastside	Greenville	South Carolina
United States	Greenville Health System Cancer Institute-Faris	Greenville	South Carolina
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	Saint Francis Hospital	Greenville	South Carolina
United States	Gibbs Cancer Center-Pelham	Greer	South Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	Smilow Cancer Hospital Care Center at Saint Francis	Hartford	Connecticut
United States	Sudarshan K Sharma MD Limted-Gynecologic Oncology	Hinsdale	Illinois
United States	Franciscan Health Indianapolis	Indianapolis	Indiana
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	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	Allegiance Health	Jackson	Michigan
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Providence Medical Center	Kansas City	Kansas
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Knoxville Gynecologic Cancer Specialists PC	Knoxville	Tennessee
United States	Sparrow Hospital	Lansing	Michigan
United States	Women's Cancer Center of Nevada	Las Vegas	Nevada
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Beebe Medical Center	Lewes	Delaware
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Saint Mary Mercy Hospital	Livonia	Michigan
United States	Central Georgia Gynecologic Oncology	Macon	Georgia
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Saint Joseph's Hospital	Marshfield	Wisconsin
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Froedtert and the Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin
United States	University of South Alabama Mitchell Cancer Institute	Mobile	Alabama
United States	Good Samaritan Regional Health Center	Mount Vernon	Illinois
United States	Mercy Health Partners-Hackley Campus	Muskegon	Michigan
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee
United States	The Hospital of Central Connecticut	New Britain	Connecticut
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Christiana Care Health System-Christiana Hospital	Newark	Delaware
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California
United States	UF Cancer Center at Orlando Health	Orlando	Florida
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Saint Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Saint Joseph Mercy Oakland	Pontiac	Michigan
United States	Lake Huron Medical Center	Port Huron	Michigan
United States	Maine Medical Center-Bramhall Campus	Portland	Maine
United States	Women and Infants Hospital	Providence	Rhode Island
United States	Black Hills Obstetrics and Gynecology	Rapid City	South Dakota
United States	Marshfield Clinic at James Beck Cancer Center	Rhinelander	Wisconsin
United States	Marshfield Clinic-Rice Lake Center	Rice Lake	Wisconsin
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Saint Mary's of Michigan	Saginaw	Michigan
United States	Mercy Hospital Saint Louis	Saint Louis	Missouri
United States	Saint Louis-Cape Girardeau CCOP	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Greenville Health System Cancer Institute-Seneca	Seneca	South Carolina
United States	Greenville Health System Cancer Institute-Spartanburg	Spartanburg	South Carolina
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Cancer Research for the Ozarks NCORP	Springfield	Missouri
United States	CoxHealth South Hospital	Springfield	Missouri
United States	Mercy Hospital Springfield	Springfield	Missouri
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	Stony Brook University Medical Center	Stony Brook	New York
United States	State University of New York Upstate Medical University	Syracuse	New York
United States	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma
United States	Carle Cancer Center	Urbana	Illinois
United States	Saint John Macomb-Oakland Hospital	Warren	Michigan
United States	Northwestern Medicine Cancer Center Warrenville	Warrenville	Illinois
United States	Marshfield Clinic-Wausau Center	Wausau	Wisconsin
United States	Aurora West Allis Medical Center	West Allis	Wisconsin
United States	Reading Hospital	West Reading	Pennsylvania
United States	Diagnostic and Treatment Center	Weston	Wisconsin
United States	Marshfield Clinic - Weston Center	Weston	Wisconsin
United States	New Hanover Regional Medical Center/Zimmer Cancer Center	Wilmington	North Carolina
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	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin
United States	University of Massachusetts Memorial Health Care	Worcester	Massachusetts
United States	Lankenau Medical Center	Wynnewood	Pennsylvania
United States	Main Line Health NCORP	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chemotherapy response	As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting chemotherapy response will be described.	Up to 10 years
Other	Optimal cut-off values for YKL-40	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
Other	Overall survival	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
Other	Progression-free survival	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
Other	Variability of CA125 measurements	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
Other	Variability of YKL-40 measurements	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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