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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

18 Years
Open (Enrolling)
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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



- 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.

- Compare the predictive accuracy of YKL-40 vs CA-125, in terms of disease response to
chemotherapy and relapse, in these patients.


- 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.

- Assess the ability of YKL-40 to predict poor outcome in these patients.

- Determine alternative cutoff values for YKL-40 elevation in these patients.

- Determine the variability of YKL-40 and CA-125 measurements in patients receiving
primary chemotherapy and in patients in primary remission.

- Determine the accuracy of YKL-40 coupled with CA-125 measurements in predicting
chemotherapy response, progression-free survival, and overall survival of these

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.

PROJECTED ACCRUAL: A total of 2,500 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed diagnosis of 1 of the following:

- Invasive ovarian epithelial cancer

- Primary peritoneal cavity cancer

- Fallopian tube cancer

- 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

- No rheumatoid arthritis, severe uncontrolled osteoarthritis, hepatic fibrosis, or
other active chronic inflammatory condition


- See Disease Characteristics

- 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

- No neoadjuvant chemotherapy prior to surgical staging

Type of Study:


Study Design:


Outcome Measure:

Objective response as measured by RECIST criteria

Safety Issue:


Principal Investigator

Carol Aghajanian, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center



Study ID:




Start Date:

September 2007

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • ovarian mixed epithelial carcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian undifferentiated adenocarcinoma
  • Brenner tumor
  • stage IIIA primary peritoneal cavity cancer
  • stage IIIB primary peritoneal cavity cancer
  • stage IIIC primary peritoneal cavity cancer
  • stage IV primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



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