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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: August 8, 2014
Last verified: August 2014
  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. A study that assesses the tumor marker YKL-40 may help doctors learn how patients respond to treatment.


Condition Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 Gynecologic Oncology Group:

Primary Outcome Measures:
  • Objective response as measured by RECIST criteria [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2500
Study Start Date: September 2007
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a histologic diagnosis of FIGO stage III or IV invasive epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that will undergo full surgical staging according to the GOG Surgical Procedures Manual and will receive primary chemotherapy for newly diagnosed disease

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899093

  Show 135 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Katherine Bell-McGuinn Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00899093     History of Changes
Other Study ID Numbers: GOG-0235, NCI-2009-01083, CDR0000540250, GOG-0235, GOG-0235, GOG-0235, U10CA027469
Study First Received: May 9, 2009
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brenner Tumor
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endometrial Neoplasms
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Urogenital Neoplasms
Uterine Neoplasms
Adenocarcinoma
Carcinoma
Carcinoma, Endometrioid
Cystadenocarcinoma
Cystadenocarcinoma, Mucinous
Cystadenocarcinoma, Serous
Adnexal Diseases
Digestive System Diseases
Endocrine System Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on November 25, 2014