Overview

This trial is active, not recruiting.

Conditions fallopian tube adenocarcinoma, fallopian tube clear cell adenocarcinoma, fallopian tube endometrioid adenocarcinoma, fallopian tube mucinous adenocarcinoma, fallopian tube serous adenocarcinoma, fallopian tube transitional cell carcinoma, malignant ovarian brenner tumor, malignant ovarian clear cell tumor, malignant ovarian endometrioid tumor, malignant ovarian mixed epithelial tumor, malignant ovarian mucinous tumor, malignant ovarian neoplasm, malignant ovarian serous tumor, malignant ovarian transitional cell tumor, ovarian adenocarcinoma, primary peritoneal serous adenocarcinoma, stage iiia fallopian tube cancer, stage iiia ovarian cancer, stage iiia primary peritoneal cancer, stage iiib fallopian tube cancer, stage iiib ovarian cancer, stage iiib primary peritoneal cancer, stage iiic fallopian tube cancer, stage iiic ovarian cancer, stage iiic primary peritoneal cancer, stage iv fallopian tube cancer, stage iv ovarian cancer, stage iv primary peritoneal cancer, undifferentiated fallopian tube carcinoma, undifferentiated ovarian carcinoma
Treatments cytology specimen collection procedure, laboratory biomarker analysis
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date September 2007
End date January 2100
Trial size 2500 participants
Trial identifier NCT00899093, CDR0000540250, GOG-0235, NCI-2009-01083, U10CA027469, U10CA180868

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients undergo collection of serum samples for analysis of YKL-40 via 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.
cytology specimen collection procedure Cytologic Sampling
Correlative studies
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
CA125 measurements
time frame: Up to 10 years
Objective response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria
time frame: Up to 10 years
Time to disease progression using RECIST criteria
time frame: Up to 10 years
Time to tumor recurrence (relapse)
time frame: From study entry until disease recurrence, death or date of last contact, assessed up to 10 years
YKL-40 measurements
time frame: Up to 10 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

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
Principal investigator Katherine Bell-McGuinn
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) 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Gynecologic Oncology Group.