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Protein Evaluation in Patients With Stage III or Stage IV Primary Peritoneal or Fallopian Tube Cancer or Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer in Remission
This study is ongoing, but not recruiting participants.
Study NCT00020033   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: May 8, 2009   History of Changes

July 11, 2001
May 8, 2009
June 2000
 
  • Create serum and body fluid proteomic profiling by surface-enhanced laser desorption and ionization with time-of-flight detection (SELDI-TOF) and artificial intelligence at baseline, 1 mo., and then every 3 mo. [ Designated as safety issue: No ]
  • Sensitivity and specificity of the serum proteomic signature profiles measured by SELDI-TOF and artificial intelligence at baseline, 1 month, and then every 3 months [ Designated as safety issue: No ]
  • Sensitivity & specificity of proteomic signature profiles of serum, body fluid and tumor biopsy compared with CA-125 serum tumor marker profiles by SELDI-TOF & artificial intelligence and serum CA-125 at baseline, 1 mo. and then every 3 mo. [ Designated as safety issue: No ]
  • Create serum and body fluid proteomic profiling by surface-enhanced laser desorption and ionization with time-of-flight detection (SELDI-TOF) and artificial intelligence at baseline, 1 mo., and then every 3 mo.
  • Sensitivity and specificity of the serum proteomic signature profiles measured by SELDI-TOF and artificial intelligence at baseline, 1 month, and then every 3 months
  • Sensitivity & specificity of proteomic signature profiles of serum, body fluid and tumor biopsy compared with CA-125 serum tumor marker profiles by SELDI-TOF & artificial intelligence and serum CA-125 at baseline, 1 mo. and then every 3 mo.
Complete list of historical versions of study NCT00020033 on ClinicalTrials.gov Archive Site
 
 
 
Protein Evaluation in Patients With Stage III or Stage IV Primary Peritoneal or Fallopian Tube Cancer or Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer in Remission
A Pilot Study of Proteomic Evaluation of Epithelial Ovarian Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile Associated With Relapse

RATIONALE: The presence of specific proteins may allow a doctor to determine whether or not cancer has relapsed.

PURPOSE: This laboratory study is studying how well protein evaluation predicts disease relapse in patients with stage III or stage IV primary peritoneal or fallopian tube cancer or stage II, stage III, or stage IV ovarian epithelial cancer that is in remission.

OBJECTIVES:

  • Create serum and body fluid protein profiles of patients with stage III or IV primary peritoneal, fallopian tube, or ovarian epithelial cancer, or stage IIC ovarian clear cell cystadenocarcinoma in first remission through relapse.
  • Analyze expressed protein profiles to try to identify a pattern or changes in patterns associated with relapse in this patient population.
  • Compare expressed protein profiles in blood and body fluids at relapse with expressed protein patterns in tumor relapse specimen of these patients.
  • Determine the associative/predictive value of serum lysophosphatidic acid measurements for ovarian cancer relapse.

OUTLINE: Patients undergo history, physical examination with pelvic examination, laboratory evaluation, and noninvasive imaging at baseline, 1 month, 3 months, and every 3 months thereafter. Samples are analyzed by surface enhanced laser desorption ionization spectrometry to identify protein profiles. Samples are also analyzed for lysophosphatidic acid. Patient evaluation continues until biopsy proven relapse.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

 
Observational
 
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Genetic: proteomic profiling
  • Other: laboratory biomarker analysis
  • Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry
  • Procedure: diagnostic imaging
 
Mehta AI, Ross S, Lowenthal MS, Fusaro V, Fishman DA, Petricoin EF 3rd, Liotta LA. Biomarker amplification by serum carrier protein binding. Dis Markers. 2003-2004;19(1):1-10.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III or IV primary peritoneal, fallopian tube, or ovarian epithelial cancer, or stage IIC ovarian clear cell cystadenocarcinoma in first clinical remission as defined by:

    • Normal CA-125
    • Normal physical exam
    • Normal post-hysterectomy pelvic examination
    • No evidence of disease on CT scan or other noninvasive reassessment
  • No nonepithelial or mixed epithelial/nonepithelial ovarian cancer
  • Completion of standard platinum/paclitaxel or carboplatin/paclitaxel-based chemotherapy with complete response

    • No more than 9 weeks since final course of chemotherapy or triple therapy (no more than 12 weeks since final dose of chemotherapy)

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy, including replacement hormonal therapy

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • No concurrent surgery

Other:

  • No concurrent alternative therapy
  • No other concurrent cancer therapy
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020033
 
CDR0000067598, NCI-00-C-0018
National Cancer Institute (NCI)
 
Study Chair: Virginia Kwitkowski, MS, RN, CS, CRNP National Cancer Institute (NCI)
National Cancer Institute (NCI)
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP