Early Detection of Ovarian Cancer: GC/FT-ICR Mass Spectrometry and Canine Olfaction
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational

Summary: 
      RATIONALE: Studying samples of exhaled breath from patients with ovarian epithelial cancer,
      polycystic ovarian syndrome, or endometriosis and from healthy participants in the laboratory
      may help doctors identify and learn more about biomarkers related to cancer. It may also help
      doctors find and diagnose ovarian epithelial cancer sooner, when it may be easier to treat.

      PURPOSE: This clinical trial is studying exhaled breath biomarkers to see how well they find
      ovarian epithelial cancer in patients with newly diagnosed ovarian epithelial cancer,
      polycystic ovarian syndrome, or endometriosis and in healthy participants.
    

Detailed description: 
      OBJECTIVES:

        -  Identify patterns of exhaled compounds in breath samples from patients with newly
           diagnosed ovarian epithelial cancer that are significantly and reproducibility different
           from those of healthy volunteers using gas chromatography Fourier transform ion
           cyclotron resonance mass spectrometry (GC/FT-ICR MS).

        -  Train five canines to discriminate between exhaled breath samples from patients with
           newly diagnosed ovarian epithelial cancer and healthy volunteers.

        -  Use both canine olfaction and GC/FT-ICR MS to distinguish between exhaled breath samples
           from patients with newly diagnosed ovarian epithelial cancer and patients with
           polycystic ovarian syndrome or endometriosis.

        -  Repeat breath sampling in patients with newly diagnosed ovarian epithelial cancer
           throughout the course of diagnosis and therapy.

      OUTLINE: Exhaled breath samples are collected from patients and healthy volunteers. The
      samples are analyzed by gas chromatography Fourier transform ion cyclotron resonance mass
      spectrometry (GC/FT-ICR MS) to determine chemical compositions, identities, and predictive
      patterns of biomarkers in exhaled breath condensate. GC/FT-ICR MS and trained canine
      olfaction are used to distinguish between exhaled breath samples from patients with ovarian
      epithelial cancer, patients with polycystic ovarian syndrome or endometriosis, and healthy
      volunteers.

      Patients and healthy volunteers complete questionnaires about BRCA 1 and BRCA 2 status (if
      known), alcohol use, smoking (including duration and type of cigarettes), physical activity
      (duration and type), socioeconomic status, education, county of residence, age at menopause
      (if applicable), age at menarche, presence of first- and second-degree family history of
      breast cancer or ovarian epithelial cancer, body mass index (height and weight), and
      co-morbidities.
    

Intervention name(s): Fourier transform ion cyclotron resonance mass spectrometry; chromatography; diagnostic laboratory biomarker analysis; questionnaire administration
Intervention type(s): Other; Other; Other; Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Histologically confirmed ovarian epithelial cancer.

          2. Polycystic Ovarian Syndrome or Endometriosis

          3. Healthy Controls
      
Keywords: ovarian epithelial cancer