Brief Title
Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass
Official Title
Pelvic Mass Study to Develop Serum Proteomic Profiles (SIGNATURES) for Epithelial Ovarian Cancer Diagnosis and Prognosis
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.
Detailed Description
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Tertiary
- 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
Primary Outcome
Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass)
Condition
Fallopian Tube Cancer
Intervention
proteomic profiling
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Genetic
Estimated Enrollment
2000
Start Date
October 2005
Primary Completion Date
October 2007
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Abnormal pelvic mass by physical examination or imaging test
- Undiagnosed
- Planning to undergo surgical evaluation within the next 3 weeks
PATIENT CHARACTERISTICS:
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Surgery
- See Disease Characteristics
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Elise C. Kohn, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00238342
Organization ID
CDR0000445437
Secondary IDs
GOG-0220
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Elise C. Kohn, MD, Study Chair, NCI - Medical Oncology Branch
Verification Date
April 2007