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
RATIONALE: A study that assesses the tumor marker YKL-40 may help doctors learn how patients respond to treatment.
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.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Other: diagnostic laboratory biomarker analysis
|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|
- Objective response as measured by RECIST criteria [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
- 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.
- Compare the predictive accuracy of YKL-40 vs CA-125, in terms of disease response to chemotherapy and relapse, in these patients.
- 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.
- Assess the ability of YKL-40 to predict poor outcome in these patients.
- Determine alternative cutoff values for YKL-40 elevation in these patients.
- Determine the variability of YKL-40 and CA-125 measurements in patients receiving primary chemotherapy and in patients in primary remission.
- 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.
PROJECTED ACCRUAL: A total of 2,500 patients will be accrued for this study.