Clinical trial NCT00757952: Early Detection of Ovarian Cancer: GC/FT-ICR Mass Spectrometry and Canine Olfaction
Official title: Early Detection of Epithelial Ovarian Cancer Using Exhaled Breath Markers: GC/FT-ICR Mass Spectrometry and Canine Olfaction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: ovarian epithelial cancer
Lead sponsor: Pine Street Foundation
Sponsor class: OTHER
First posted: 2008-09-23
Enrollment: 109
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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

Brief 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.

Eligibility 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

Primary outcomes:
measure: Identification of patterns of exhaled compounds in breath samples using gas chromatography Fourier transform ion cyclotron resonance mass spectrometry (GC/FT-ICR MS)
timeFrame: 2009-2012
measure: Diagnostic accuracy of GC/FT-ICR MS in distinguishing between exhaled breath samples from patients with ovarian epithelial cancer, patients with polycystic ovarian syndrome or endometriosis, and healthy volunteers
timeFrame: 2009-2012
measure: Diagnostic accuracy of canine scent detection in distinguishing between exhaled breath samples from patients with ovarian epithelial cancer and healthy volunteers
timeFrame: 2009-2012
Secondary outcomes:
Other outcomes:
Locations:
city: San Anselmo
country: United States
facility: Pine Street Foundation
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - California Campus
state: California
city: Orono
country: United States
facility: University of Maine
state: Maine
Study officials:
affiliation: Pine Street Foundation
name: Michael McCulloch, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: