Early Detection of Ovarian Cancer: GC/FT-ICR Mass Spectrometry and Canine Olfaction

Pine Street Foundation

Status: Completed

Conditions: Ovarian Cancer

Treatments: Other: questionnaire administration; Other: Fourier transform ion cyclotron resonance mass spectrometry; Other: chromatography; Other: diagnostic laboratory biomarker analysis

Study type: Observational

Funder types: Other

Identifiers

NCT00757952

PINE-A-14183

CDR0000614811 (Registry Identifier)

UCSF-H105-31440-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: Female

Ages: 21 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Meets one of the following criteria:

  • Histologically confirmed ovarian epithelial cancer

    • Newly diagnosed disease

  • Diagnosis of polycystic ovarian syndrome or endometriosis

  • Healthy volunteer meeting all of the following criteria:

    • No prior ovarian cancer (including invasive ovarian epithelial cancer, fallopian tube cancer, or primary papillary serous carcinoma of the peritoneum)
    • No prior breast cancer (including ductal carcinoma in situ [DCIS])
    • No prior ovarian or breast cancer (including DCIS) in any first- or second-degree relative
    • BRCA1 or BRCA2 mutation negative (if known) OR no first- or second-degree relative with a BRCA1 or BRCA2 mutation (if known)

• No prior diagnosis of cancer

PATIENT CHARACTERISTICS:

• Lives in California and close to the study sampling centers
• Reads and writes English, Spanish, or Chinese
• Non-smoker
• Willing to provide breath samples
• No alcohol intake within the past 3 days

PRIOR CONCURRENT THERAPY:

• At least 3 days since prior Cox-2 inhibitors, vitamin E, omega-3 fatty acids, antioxidants, bromelain, coenzyme Q10, curcumin, or vitamin A