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

• CA125 measurements [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  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 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  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 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  Parallel statistical analyses of time to disease progression will also be conducted for patients who do not respond.
  
  
• Time to tumor recurrence (relapse) [ Time Frame: From study entry until disease recurrence, death or date of last contact, assessed up to 10 years ] [ Designated as safety issue: No ]
  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 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  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.
  
  

• Chemotherapy response [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  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 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  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 [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 10 years ] [ Designated as safety issue: No ]
  As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting overall survival will be described.
  
  
• Progression-free survival [ Time Frame: From study entry until disease progression, death or date of last contact, assessed up to 10 years ] [ Designated as safety issue: No ]
  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 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  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 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  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.
  
  

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.