Clinical Trials Directory

Trials / Terminated

TerminatedNCT00899093

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

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

Status
Terminated
Phase
—
Study type
Observational
Enrollment
2,500 (estimated)
Sponsor
Gynecologic Oncology Group · Network
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

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) 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.

Conditions

Interventions

TypeNameDescription
OTHERCytology Specimen Collection ProcedureCorrelative studies
OTHERLaboratory Biomarker AnalysisCorrelative studies

Timeline

Start date
2007-09-01
Primary completion
2016-06-01
First posted
2009-05-12
Last updated
2018-05-22

Locations

131 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00899093. Inclusion in this directory is not an endorsement.