|No phase specified||Biomarker/Laboratory analysis||Closed||18 and over||NCI, Other||GOG-0235|
NCI-2009-01083, CDR0000540250, U10CA027469, NCT00899093
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. A study that assesses the tumor marker YKL-40 may help doctors learn how patients respond to treatment.
Further Study Information
I. 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.
II. Compare the predictive accuracy of YKL-40 vs CA-125, in terms of disease response to chemotherapy and relapse, in these patients.
I. 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.
II. Assess the ability of YKL-40 to predict poor outcome in these patients.
I. Determine alternative cutoff values for YKL-40 elevation in these patients. II. Determine the variability of YKL-40 and CA-125 measurements in patients receiving primary chemotherapy and in patients in primary remission.
III. 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.
- Histologically confirmed diagnosis of 1 of the following:
- Invasive ovarian epithelial cancer
- Primary peritoneal cavity cancer
- Fallopian tube cancer
- Federation of Gynecology and Obstetrics (FIGO) stage III or IV disease
- The following histologic cell types are allowed:
- Serous adenocarcinoma
- Mucinous adenocarcinoma
- Endometrioid adenocarcinoma
- Clear cell adenocarcinoma
- Transitional cell carcinoma
- Mixed epithelial carcinoma
- Undifferentiated carcinoma
- Adenocarcinoma not otherwise specified
- Malignant Brenner tumor
- The following histologic cell types are not allowed:
- Carcinosarcoma (i.e., malignant mixed Müllerian tumor)
- Borderline epithelial tumors (i.e., low malignant potential or atypical proliferative tumors)
- Patients with a prior diagnosis of a borderline tumor that was surgically resected who subsequently develop an unrelated, new, invasive ovarian epithelial or peritoneal primary cancer are eligible provided patient received no prior chemotherapy for any ovarian tumor
- Newly diagnosed disease AND planning to receive primary chemotherapy
- Has undergone full surgical staging
- No recurrent invasive ovarian epithelial cancer treated with surgery only (e.g., stage IA or IB low-grade lesions)
- No synchronous primary endometrial cancer or prior endometrial cancer unless all of the following criteria are met:
- Stage IA or IB disease
- Superficial myometrial invasion without vascular or lymphatic invasion
- No poorly differentiated subtypes (e.g., papillary serous, clear cell, or other FIGO grade 3 lesions)
- No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
- No rheumatoid arthritis, severe uncontrolled osteoarthritis, hepatic fibrosis, or other active chronic inflammatory condition
- No neoadjuvant chemotherapy prior to surgical staging
- More than 3 years since prior adjuvant chemotherapy for localized breast cancer AND no recurrent or metastatic disease
- No prior cancer treatment that contraindicates study therapy
- No prior chemotherapy for any abdominal or pelvic tumor
Trial Lead Organizations/Sponsors
Gynecologic Oncology GroupNational Cancer Institute
|Katherine Bell-McGuinn||Principal Investigator|
|M.D. Anderson Cancer Center at Orlando|
|Veronica L Schimp||Ph: 321-841-7246|
|St. Vincent Oncology Center|
|Gregory P. Sutton||Ph: 317-338-2194|
|Saint Luke's Cancer Institute at Saint Luke's Hospital|
|Rakesh Gaur||Ph: 913-948-5588|
|David Griffin||Ph: 864-512-1000|
|Gynecologic Oncology Group|
|Katherine M Bell-McGuinn||Ph: 646-888-4221|
|University of Texas Medical Branch|
|Lyuba Levine||Ph: 409-772-1950|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00899093
ClinicalTrials.gov processed this data on March 17, 2014
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