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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00899093
First received: May 9, 2009
Last updated: March 17, 2014
Last verified: March 2014

May 9, 2009
March 17, 2014
September 2007
January 2100   (final data collection date for primary outcome measure)
Objective response as measured by RECIST criteria [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
Objective response as measured by RECIST criteria [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00899093 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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 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

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.

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

TERTIARY OBJECTIVES:

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with Stage III or IV ovarian, primary peritoneal or fallopian tube cancer

  • Brenner Tumor
  • Fallopian Tube Cancer
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mixed Epithelial Carcinoma
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Undifferentiated Adenocarcinoma
  • Primary Peritoneal Cavity Cancer
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
Other: laboratory biomarker analysis
Correlative studies
Ancillary-Correlative (blood collection)
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.
Intervention: Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2500
Not Provided
January 2100   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00899093
GOG-0235, NCI-2009-01083, CDR0000540250, GOG-0235, GOG-0235, GOG-0235, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Katherine Bell-McGuinn Gynecologic Oncology Group
Gynecologic Oncology Group
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP