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

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ClinicalTrials.gov Identifier: NCT00757952
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Ovarian Cancer Other: Fourier transform ion cyclotron resonance mass spectrometry Other: chromatography Other: diagnostic laboratory biomarker analysis Other: questionnaire administration

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.


Study Design

Study Type : Observational
Actual Enrollment : 109 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Early Detection of Epithelial Ovarian Cancer Using Exhaled Breath Markers: GC/FT-ICR Mass Spectrometry and Canine Olfaction.
Study Start Date : November 2007
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Identification of patterns of exhaled compounds in breath samples using gas chromatography Fourier transform ion cyclotron resonance mass spectrometry (GC/FT-ICR MS) [ Time Frame: 2009-2012 ]
  2. 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 [ Time Frame: 2009-2012 ]
  3. Diagnostic accuracy of canine scent detection in distinguishing between exhaled breath samples from patients with ovarian epithelial cancer and healthy volunteers [ Time Frame: 2009-2012 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Histologically confirmed ovarian epithelial cancer.
  2. Polycystic Ovarian Syndrome or Endometriosis
  3. Healthy Controls
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757952


Locations
United States, California
Pine Street Foundation
San Anselmo, California, United States, 94960-2674
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118
United States, Maine
University of Maine
Orono, Maine, United States, 04469
Sponsors and Collaborators
Pine Street Foundation
Investigators
Principal Investigator: Michael McCulloch, MPH, PhD Pine Street Foundation
More Information

Responsible Party: Michael McCulloch, Principal Investigator, Pine Street Foundation
ClinicalTrials.gov Identifier: NCT00757952     History of Changes
Other Study ID Numbers: PINE-A-14183
CDR0000614811 ( Registry Identifier: PDQ (Physician Data Query) )
UCSF-H105-31440-01
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016

Keywords provided by Michael McCulloch, Pine Street Foundation:
ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders