A Pilot Study of a Protein Profile Test in Ovarian Cancer Patients in Remission to See if Protein Changes Can Predict Relapse (be Predictive of Cancer Relapse)
Condition: Ovarian Neoplasm
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational

Summary: 
      Every cell in the human body contains hundreds of thousands of genes and the proteins made by
      the genes. Sometimes changes take place in the genes or proteins that may make the cells more
      likely to develop into cancer. An experimental protein profile test that finds these changes
      may be able to provide information about whose cancer will stay in remission and whose will
      return.

      Volunteer patients whose epithelial ovarian cancer is in remission are eligible for this
      study. Specimens will be collected from blood, saliva, and urine for the first protein
      profile test. Sample sets for more protein profile tests will be collected at follow-up
      visits 1 month and 3 months later and every 3 months afterward. If and when the cancer
      returns, an additional sample set will be obtained and a biopsy of the relapsed tumor will be
      taken both for a protein profile test and for review of the function and structure of the
      disease (pathology review). The protein profiles from these samples will be compared to those
      samples already collected to detect protein pattern changes. The amount of lysophosphatidic
      acid (LPA) in the blood, a sign of ovarian cancer, will also be measured to see if LPA is
      useful in detecting the return of ovarian cancer.

      If patients get fluid in the stomach or chest, it will be tested for cancer cells and
      proteins made by the tumor. If a physical exam or CT scan indicates a possible return of the
      cancer, a biopsy will be performed and a sample saved for a protein profile.
    

Detailed description: 
      Over 80 percent of advanced stage epithelial cancer patients relapse after attaining first
      clinical remission with standard platinum/paclitaxel-based chemotherapy. Surrogate biomarkers
      are needed for the evaluation of efficacy of treatment and for use as predictors of disease
      in screening and for relapse diagnosis. CA-125, the existing ovarian cancer marker, will
      become elevated with relapse in some but not all of the 80 percent of patients for whom it
      was increased at initial diagnosis. Elevation in CA-125 may precede clinical evidence of
      relapse by as much as 6 - 10 months or lag behind clinical relapse by the same time
      intervals, making it a less than satisfactory clinical tool. Emerging proteomic technologies
      allow for scanning of cellular proteins in a simple, short, reproducible, and quantitative
      chemical assay. We hypothesize that changes in a patient s protein pattern will be detectable
      and will be reliably associated with relapse. This protocol is a pilot study for our ability
      to ascertain and evaluate samples from ovarian cancer patients followed in first clinical
      remission, and investigate whether analysis of sequential protein fingerprints will yield a
      reproducible pattern of change that may be associated with relapse.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary clinical population of patients in first clinical remisssion from treatment of FIGO
        stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma or stage
        II clear cell histology epithelial ovarian cancer. Entry within 12 weeks of last
        administration of chemotherapy. S/P completion of primary therapy with standard
        platinum/paclitaxel or carboplatin/paclitaxel-containing chemotherapy and in inconfirmed
        clinical complete response.
      
Biospecimen description: 
      whole blood, serum, plasma, urine, pleural/peritoneal fluid, tissue
    
Keywords: Ovarian Cancer; Proteomics