Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00238342
Recruitment Status : Unknown
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : October 13, 2005
Last Update Posted : February 9, 2010
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Finding specific proteins in the blood may help doctors tell whether a patient has ovarian cancer.

PURPOSE: This clinical trial is studying how well proteomic profiling works in diagnosing ovarian cancer in patients who are undergoing surgery for an abnormal pelvic mass.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Genetic: proteomic profiling Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry Procedure: biopsy Not Applicable

Detailed Description:



  • Generate and validate a serum proteomic profile that can predict the presence of invasive ovarian epithelial cancer using preoperative serum specimens obtained from patients undergoing surgical evaluation for an abnormal pelvic mass.


  • Generate a proteomic profile that can distinguish early- from late-stage invasive ovarian epithelial cancer using preoperative serum specimens from patients who are subsequently diagnosed with invasive ovarian epithelial cancer.


  • Determine whether serum proteomic profiling can predict the presence of postoperative residual disease in these patients.
  • Determine whether serum proteomic profiling can predict prognosis in these patients.

OUTLINE: This is a pilot, two-part, multicenter study.

  • Part A: Within 3 weeks prior to surgical evaluation, patients undergo collection of serum specimen for proteomic profiling using surface-enhanced or matrix-associated laser desorption ionization spectrometry-time of flight detection (SELDI/MALDI-TOF). Patients then undergo surgical evaluation (i.e., biopsy and/or resection) of the pelvic mass. Patients who are diagnosed with invasive ovarian epithelial adenocarcinoma or papillary serous fallopian tube carcinoma (no low malignant potential tumors) AND are without postoperative infection proceed to part B of the study.
  • Part B: Patients undergo collection of postoperative serum specimen for proteomic profiling using SELDI/MALDI-TOF within 3-8 weeks after surgery, before starting chemotherapy, and at end of chemotherapy.

After completion of study procedures, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Primary Purpose: Diagnostic
Official Title: Pelvic Mass Study to Develop Serum Proteomic Profiles (SIGNATURES) for Epithelial Ovarian Cancer Diagnosis and Prognosis
Study Start Date : October 2005
Estimated Primary Completion Date : October 2007

Primary Outcome Measures :
  1. Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Abnormal pelvic mass by physical examination or imaging test

    • Undiagnosed
  • Planning to undergo surgical evaluation within the next 3 weeks


Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Negative pregnancy test



  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00238342

  Show 107 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Elise C. Kohn, MD NCI - Medical Oncology Branch
OverallOfficial: Samir N. Khleif, MD National Cancer Institute (NCI)
OverallOfficial: Larry J. Copeland, MD Ohio State University Comprehensive Cancer Center Identifier: NCT00238342     History of Changes
Other Study ID Numbers: CDR0000445437
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: February 9, 2010
Last Verified: April 2007

Keywords provided by National Cancer Institute (NCI):
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
ovarian clear cell cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian mucinous cystadenocarcinoma
ovarian serous cystadenocarcinoma
ovarian undifferentiated adenocarcinoma

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases