Status:
TERMINATED
YKL-40 in Serum Samples From Patients With Newly Diagnosed Stage III-IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer Receiving Chemotherapy
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fallopian Tube Adenocarcinoma
Fallopian Tube Clear Cell Adenocarcinoma
Eligibility:
FEMALE
18+ years
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 f...
Detailed Description
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) ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT00899093
Start Date
September 1 2007
Last Update
May 22 2018
Active Locations (131)
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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