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.
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
2,500
Correlative studies
Correlative studies
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Highlands Oncology Group PA - Fayetteville
Fayetteville, Arkansas, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
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.
Time frame: Up to 10 years
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.
Time frame: Up to 10 years
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.
Time frame: Up to 10 years
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.
Time frame: From study entry until disease recurrence, death or date of last contact, assessed up to 10 years
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.
Time frame: Up to 10 years
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