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 (Other)

Overall Status

Terminated

CT.gov ID

NCT00899093

Collaborator

National Cancer Institute (NCI) (NIH)

2,500

Enrollment

131

Locations

19.1

Patients Per Site

Study Details

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	Phase
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:

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.
To compare the predictive accuracy of YKL-40 with cancer antigen 125 (CA125).

SECONDARY OBJECTIVES:

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.
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:

To explore alternative cut-off values for YKL-40 elevation in this large patient population.
To describe the variability of YKL-40 and CA125 measurements in patients receiving primary chemotherapy and in primary remission in a large patient population.
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

Anticipated 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 :

Sep 1, 2007

Actual Primary Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	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 Names: Cytologic Sampling Other: Laboratory Biomarker Analysis Correlative studies

Arm

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 Names:

Cytologic Sampling

Other: Laboratory Biomarker Analysis

Correlative studies

Outcome Measures

Primary Outcome Measures

CA125 measurements [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.
Objective response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria [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.
Time to disease progression using RECIST criteria [Up to 10 years]
Parallel statistical analyses of time to disease progression will also be conducted for patients who do not respond.
Time to tumor recurrence (relapse) [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.
YKL-40 measurements [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

Chemotherapy response [Up to 10 years]
As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting chemotherapy response will be described.
Optimal cut-off values for YKL-40 [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.
Overall survival [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.
Progression-free survival [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.
Variability of CA125 measurements [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.
Variability of YKL-40 measurements [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of South Alabama Mitchell Cancer Institute	Mobile	Alabama	United States	36688
2	Saint Joseph's Hospital and Medical Center	Phoenix	Arizona	United States	85013
3	Highlands Oncology Group PA - Fayetteville	Fayetteville	Arkansas	United States	72703
4	Providence Saint Joseph Medical Center/Disney Family Cancer Center	Burbank	California	United States	91505
5	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
6	Hartford Hospital	Hartford	Connecticut	United States	06102
7	Smilow Cancer Hospital Care Center at Saint Francis	Hartford	Connecticut	United States	06105
8	The Hospital of Central Connecticut	New Britain	Connecticut	United States	06050
9	Beebe Medical Center	Lewes	Delaware	United States	19958
10	Christiana Care Health System-Christiana Hospital	Newark	Delaware	United States	19718
11	UF Cancer Center at Orlando Health	Orlando	Florida	United States	32806
12	Northside Hospital	Atlanta	Georgia	United States	30342
13	Central Georgia Gynecologic Oncology	Macon	Georgia	United States	31201
14	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho	United States	83706
15	Saint Anthony's Health	Alton	Illinois	United States	62002
16	Sudarshan K Sharma MD Limted-Gynecologic Oncology	Hinsdale	Illinois	United States	60521
17	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
18	Carle Cancer Center	Urbana	Illinois	United States	61801
19	Northwestern Medicine Cancer Center Warrenville	Warrenville	Illinois	United States	60555
20	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202
21	Franciscan Health Indianapolis	Indianapolis	Indiana	United States	46237
22	Saint Vincent Hospital and Health Care Center	Indianapolis	Indiana	United States	46260
23	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
24	Iowa-Wide Oncology Research Coalition NCORP	Des Moines	Iowa	United States	50309
25	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa	United States	50309
26	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa	United States	50314
27	Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
28	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
29	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242
30	Providence Medical Center	Kansas City	Kansas	United States	66112
31	Saint Elizabeth Medical Center South	Edgewood	Kentucky	United States	41017
32	Baptist Health Lexington	Lexington	Kentucky	United States	40503
33	Woman's Hospital	Baton Rouge	Louisiana	United States	70817
34	Maine Medical Center-Bramhall Campus	Portland	Maine	United States	04102
35	Union Hospital of Cecil County	Elkton	Maryland	United States	21921
36	Baystate Medical Center	Springfield	Massachusetts	United States	01199
37	University of Massachusetts Memorial Health Care	Worcester	Massachusetts	United States	01605
38	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106-0995
39	Michigan Cancer Research Consortium NCORP	Ann Arbor	Michigan	United States	48106
40	Beaumont Hospital-Dearborn	Dearborn	Michigan	United States	48124
41	Saint John Hospital and Medical Center	Detroit	Michigan	United States	48236
42	Hurley Medical Center	Flint	Michigan	United States	48502
43	Genesys Regional Medical Center	Grand Blanc	Michigan	United States	48439
44	Cancer Research Consortium of West Michigan NCORP	Grand Rapids	Michigan	United States	49503
45	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan	United States	49503
46	Allegiance Health	Jackson	Michigan	United States	49201
47	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
48	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
49	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
50	Sparrow Hospital	Lansing	Michigan	United States	48912
51	Saint Mary Mercy Hospital	Livonia	Michigan	United States	48154
52	Mercy Health Partners-Hackley Campus	Muskegon	Michigan	United States	49442
53	Saint Joseph Mercy Oakland	Pontiac	Michigan	United States	48341
54	Lake Huron Medical Center	Port Huron	Michigan	United States	48060
55	Saint Mary's of Michigan	Saginaw	Michigan	United States	48601
56	Saint John Macomb-Oakland Hospital	Warren	Michigan	United States	48093
57	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
58	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
59	Saint Luke's Hospital of Kansas City	Kansas City	Missouri	United States	64111
60	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
61	Mercy Hospital Saint Louis	Saint Louis	Missouri	United States	63141
62	Saint Louis-Cape Girardeau CCOP	Saint Louis	Missouri	United States	63141
63	Cancer Research for the Ozarks NCORP	Springfield	Missouri	United States	65804
64	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
65	CoxHealth South Hospital	Springfield	Missouri	United States	65807
66	Billings Clinic Cancer Center	Billings	Montana	United States	59101
67	Nebraska Methodist Hospital	Omaha	Nebraska	United States	68114
68	Women's Cancer Center of Nevada	Las Vegas	Nevada	United States	89169
69	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
70	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
71	Island Gynecologic Oncology	Brightwaters	New York	United States	11718
72	New York Hospital Medical Center of Queens	Fresh Meadows	New York	United States	11365
73	Winthrop University Hospital	Mineola	New York	United States	11501
74	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
75	Stony Brook University Medical Center	Stony Brook	New York	United States	11794
76	State University of New York Upstate Medical University	Syracuse	New York	United States	13210
77	Novant Health Presbyterian Medical Center	Charlotte	North Carolina	United States	28204
78	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
79	New Hanover Regional Medical Center/Zimmer Cancer Center	Wilmington	North Carolina	United States	28401
80	Southeast Clinical Oncology Research (SCOR) Consortium NCORP	Winston-Salem	North Carolina	United States	27104
81	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
82	Summa Akron City Hospital/Cooper Cancer Center	Akron	Ohio	United States	44304
83	Akron General Medical Center	Akron	Ohio	United States	44307
84	Aultman Health Foundation	Canton	Ohio	United States	44710
85	Good Samaritan Hospital - Cincinnati	Cincinnati	Ohio	United States	45220
86	MetroHealth Medical Center	Cleveland	Ohio	United States	44109
87	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210
88	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
89	Miami Valley Hospital	Dayton	Ohio	United States	45409
90	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
91	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma	United States	74146
92	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
93	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania	United States	19010
94	Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301
95	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
96	Reading Hospital	West Reading	Pennsylvania	United States	19611
97	Lankenau Medical Center	Wynnewood	Pennsylvania	United States	19096
98	Main Line Health NCORP	Wynnewood	Pennsylvania	United States	19096
99	Women and Infants Hospital	Providence	Rhode Island	United States	02905
100	AnMed Health Cancer Center	Anderson	South Carolina	United States	29621
101	Saint Francis Hospital	Greenville	South Carolina	United States	29601
102	Greenville Health System Cancer Institute-Faris	Greenville	South Carolina	United States	29605
103	Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
104	Greenville Health System Cancer Institute-Eastside	Greenville	South Carolina	United States	29615
105	Gibbs Cancer Center-Pelham	Greer	South Carolina	United States	29651
106	Greenville Health System Cancer Institute-Seneca	Seneca	South Carolina	United States	29672
107	Spartanburg Medical Center	Spartanburg	South Carolina	United States	29303
108	Greenville Health System Cancer Institute-Spartanburg	Spartanburg	South Carolina	United States	29307
109	Black Hills Obstetrics and Gynecology	Rapid City	South Dakota	United States	57701
110	Knoxville Gynecologic Cancer Specialists PC	Knoxville	Tennessee	United States	37920
111	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee	United States	37232
112	The Don and Sybil Harrington Cancer Center	Amarillo	Texas	United States	79106
113	Baylor All Saints Medical Center at Fort Worth	Fort Worth	Texas	United States	76104
114	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia	United States	23298
115	Marshfield Clinic Cancer Center at Sacred Heart	Eau Claire	Wisconsin	United States	54701
116	Sacred Heart Hospital	Eau Claire	Wisconsin	United States	54701
117	Aurora BayCare Medical Center	Green Bay	Wisconsin	United States	54311
118	Marshfield Clinic	Marshfield	Wisconsin	United States	54449
119	Saint Joseph's Hospital	Marshfield	Wisconsin	United States	54449
120	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
121	Froedtert and the Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
122	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin	United States	54548
123	Marshfield Clinic at James Beck Cancer Center	Rhinelander	Wisconsin	United States	54501
124	Marshfield Clinic-Rice Lake Center	Rice Lake	Wisconsin	United States	54868
125	Marshfield Clinic Cancer Care at Saint Michael's Hospital	Stevens Point	Wisconsin	United States	54481
126	Saint Michael's Hospital	Stevens Point	Wisconsin	United States	54481
127	Marshfield Clinic-Wausau Center	Wausau	Wisconsin	United States	54401
128	Aurora West Allis Medical Center	West Allis	Wisconsin	United States	53227
129	Diagnostic and Treatment Center	Weston	Wisconsin	United States	54476
130	Marshfield Clinic - Weston Center	Weston	Wisconsin	United States	54476
131	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494