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Early Detection of Epithelial Ovarian Cancer Using Exhaled Breath Markers: GC/FT-ICR Mass Spectrometry and Canine Olfaction.


N/A
21 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

Early Detection of Epithelial Ovarian Cancer Using Exhaled Breath Markers: GC/FT-ICR Mass Spectrometry and Canine Olfaction.


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

Identification of patterns of exhaled compounds in breath samples using gas chromatography Fourier transform ion cyclotron resonance mass spectrometry (GC/FT-ICR MS)

Safety Issue:

No

Principal Investigator

Michael McCulloch, MPH, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Pine Street Foundation

Authority:

Unspecified

Study ID:

CDR0000614811

NCT ID:

NCT00757952

Start Date:

November 2007

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • ovarian epithelial cancer
  • Ovarian Neoplasms
  • Polycystic Ovary Syndrome
  • Neoplasms, Glandular and Epithelial

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
California Pacific Medical Center - California CampusSan Francisco, California  94118
Pine Street FoundationSan Anselmo, California  94960-2674
University of MaineOrono, Maine  04469