Trial record 2 of 5 for:    ykl-40 | Open Studies

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 currently recruiting participants.
Verified October 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899093
First received: May 9, 2009
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

RATIONALE: A study that assesses the tumor marker YKL-40 may help doctors learn how patients respond to treatment.

PURPOSE: 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.


Condition Intervention
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Other: diagnostic laboratory biomarker analysis

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response as measured by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: September 2007
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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 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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899093

  Show 101 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Carol Aghajanian, MD Memorial Sloan-Kettering Cancer Center
Investigator: Jakob Dupont, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00899093     History of Changes
Other Study ID Numbers: CDR0000540250, GOG-0235
Study First Received: May 9, 2009
Last Updated: October 24, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 22, 2013