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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):
Michael McCulloch, Pine Street Foundation

Tracking Information
First Submitted Date September 22, 2008
First Posted Date September 23, 2008
Last Update Posted Date March 30, 2016
Study Start Date November 2007
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2016)
  • 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 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures
 (submitted: September 22, 2008)
  • Identification of patterns of exhaled compounds in breath samples using gas chromatography Fourier transform ion cyclotron resonance mass spectrometry (GC/FT-ICR MS)
  • 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
  • Diagnostic accuracy of canine scent detection in distinguishing between exhaled breath samples from patients with ovarian epithelial cancer and healthy volunteers
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population
  1. Histologically confirmed ovarian epithelial cancer.
  2. Polycystic Ovarian Syndrome or Endometriosis
  3. Healthy Controls
Condition Ovarian Cancer
Intervention
  • Other: Fourier transform ion cyclotron resonance mass spectrometry
  • Other: chromatography
  • Other: diagnostic laboratory biomarker analysis
  • Other: questionnaire administration
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 28, 2016)
109
Original Estimated Enrollment
 (submitted: September 22, 2008)
120
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 21 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00757952
Other Study ID Numbers PINE-A-14183
CDR0000614811 ( Registry Identifier: PDQ (Physician Data Query) )
UCSF-H105-31440-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michael McCulloch, Pine Street Foundation
Study Sponsor Pine Street Foundation
Collaborators Not Provided
Investigators
Principal Investigator: Michael McCulloch, MPH, PhD Pine Street Foundation
PRS Account Pine Street Foundation
Verification Date March 2016